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Preparation H

Preparation H is an American brand of medications that is made by Pfizer, used in the treatment of hemorrhoids. Hemorrhoids are caused at least in part by inflamed blood vessels, and most versions of Preparation H work by reducing inflammation in blood vessels.

The company that makes this product incorporated in 1926 as American Home Products (AHP) and "one of AHP's earliest prizes was the acquisition of a sunburn oil in 1935 that the company transformed into Preparation H, which became one of the world's best-selling hemorrhoid treatments."[1] AHP changed its name to Wyeth in 2002, and was then bought by Pfizer in 2009, which was reported to have paid $68 billion.[2]

Formulations

[edit]

Several formulations have been produced.[3] Some are in a water-based gel while others are petroleum jelly-based, and the suppositories use a base of cocoa butter. It also comes as a medicated wipe. The active ingredients range from simple caffeine moisturizers with witch-hazel astringent to preparations containing drugs such as phenylephrine, pramoxine, and hydrocortisone. Formulations vary from one country to another. Some Preparation H products have phenylephrine, a drug that constricts blood vessels, in a 0.25% concentration, as well as shark liver oil.[4] Another version of Preparation H has hydrocortisone as its only active ingredient in a 1% concentration.[citation needed]

The Canadian formulation of Preparation H includes a yeast extract called Biodyne which was removed in 1995 from the formulation sold in the United States. This yeast extract was the primary ingredient of the original formulation by inventor George Sperti,[5][6] and Pfizer believes that it removes wrinkles from skin and heals dry, cracked, and irritated skin. The Canadian formulation has acquired a market in the United States as a skin cream with an anti-wrinkle active ingredient.[citation needed] In Greece, the active ingredients of Preparation H are 1% w/w yeast extract and 3% w/w shark liver oil.[7]

References

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Preparation H

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Preparation H is a brand of over-the-counter topical medications primarily used for the temporary relief of symptoms associated with , including pain, soreness, burning, itching, and discomfort, while also helping to shrink swollen hemorrhoidal tissue. The products are available in various forms, such as creams, ointments, suppositories, gels, and medicated wipes, making them suitable for both internal and external application. Key active ingredients in most formulations include , a vasoconstrictor that reduces swelling by constricting blood vessels, and pramoxine hydrochloride, a local anesthetic that numbs pain and itching. Additional components often feature protectants like , petrolatum, and glycerin to soothe and lubricate the affected area, with some variants incorporating or for enhanced comfort. The brand originated in 1935 when Dr. George Sperti, an Italian-American inventor and researcher at the Institutum Divi Thomae in , , developed an ointment initially known as Sperti Ointment during studies on and cancer. The original formula contained and live cell derivative (LYCD), a bioactive extract intended to promote tissue repair, which was later marketed under the name Preparation H specifically for treatment by Whitehall Laboratories, a division of American Home Products. Over the decades, the product's ownership evolved through corporate : American Home Products became in 2002, which was acquired by in 2009, and in 2022, spun off its consumer healthcare division into , the current manufacturer and owner of the brand. Modern U.S. formulations no longer include LYCD due to regulatory challenges with FDA testing in the 1990s, though versions sold in retain it. Preparation H has become one of the most recognized and doctor-recommended over-the-counter treatments for in the United States, with products emphasizing rapid multi-symptom relief and ease of use. While effective for symptomatic management, the brand's labeling advises consulting a healthcare professional for persistent symptoms or if using alongside prescription medications for conditions like high or depression, due to potential interactions with . The product's enduring popularity stems from its long history of and to needs, positioning it as a staple in care.

History

Invention and Early Development

George Speri Sperti, an Italian-American inventor born on January 17, 1900, in , graduated from the in 1923 with a degree in . By 1927, he had become director of the university's Basic Science Research Laboratory, where he pioneered work on (UV) lamps, including the development of a sunlamp and a process patented in 1927 for irradiating milk to produce and combat . Sperti held numerous patents prior to his work on Preparation H, focusing on innovations in , , and nutritional enhancement through processes. In , after leaving the to found the Institutum Divi Thomae research institute in , Sperti developed an ointment originally intended as a sunburn relief formula, incorporating and live yeast cell derivative (known as Biodyne), which promoted and reduced inflammation. That same year, American Home Products acquired the rights to this ointment and repositioned it specifically for treating by leveraging its anti-inflammatory properties on blood vessels. Initially formulated as a general treatment, the product was refined and rebranded as Preparation H, and launched around as a targeted over-the-counter (OTC) remedy for anorectal conditions by Whitehall Laboratories, a division of American Home Products. Preparation H quickly gained popularity for its soothing effects derived from the original bio-dyne and components. Sperti's invention became one of his most enduring contributions, underscoring his prolific career that amassed over 120 patents in fields ranging from medical ointments to techniques. He passed away on April 29, 1991, at age 91 in .

Corporate Ownership and Evolution

Preparation H's corporate origins trace back to the incorporation of American Home Products (AHP) in 1926 as a focused on consumer goods and pharmaceuticals. In 1935, AHP acquired rights to an experimental ointment initially developed for sunburn relief, which it reformulated and launched as Preparation H, marking the brand's entry into the over-the-counter (OTC) market for treatment. This early development positioned AHP as a key player in household remedies, with Preparation H quickly gaining traction as a specialized product. Through a series of mergers and internal restructurings, AHP evolved significantly in the late 20th and early 21st centuries. In , following the consolidation of its diverse portfolio and a shift toward pharmaceuticals, AHP rebranded itself as to reflect its global focus on research-based medicines and consumer health products. This rebranding streamlined operations and emphasized innovation in OTC brands like Preparation H. In January 2009, announced its acquisition of for $68 billion, one of the largest pharmaceutical deals at the time, integrating Preparation H into 's expansive consumer healthcare division and enhancing its distribution and marketing capabilities worldwide. The deal was completed in October 2009 after regulatory approvals. In 2022, Pfizer's consumer healthcare business, which included Preparation H, was contributed to a with GlaxoSmithKline (GSK), leading to the demerger and formation of plc as an independent company listed on the London Stock Exchange. assumed ownership and management of Preparation H, focusing on its growth in the consumer health sector. As of 2025, remains the current owner, continuing to market the brand globally. Under these corporate evolutions—from AHP's niche acquisition to Wyeth's expansion, Pfizer's integration, and 's specialization—Preparation H transformed from a single experimental product into the leading OTC treatment in the United States, generating hundreds of millions in annual sales. A pivotal aspect of the brand's evolution was its alignment with U.S. regulatory standards for OTC status. In 1990, the FDA published the final for OTC anorectal drug products (21 CFR Part 346), establishing safety and efficacy guidelines for ingredients like protectants and vasoconstrictors used in treatments. Preparation H reformulated to comply, removing non-compliant components such as while retaining approved actives, securing its ongoing OTC availability and contributing to its market dominance. This regulatory milestone, effective from the monograph's implementation, solidified Preparation H's position as a trusted, accessible remedy.

Medical Uses

Indications for Hemorrhoids

are swollen and inflamed veins around the or in the lower that can cause symptoms such as swelling, burning, pain, itching, and general discomfort. is an over-the-counter product designed to provide symptomatic relief for these conditions rather than serving as a cure for the underlying . The U.S. (FDA) approves Preparation H for the temporary relief of pain, soreness, burning, itching, and discomfort associated with external and internal , as well as for temporarily shrinking swollen hemorrhoidal tissue. It may also be used during , but only after consulting a healthcare professional. For recommended usage, adults and children over 12 years of age should cleanse the affected area, then apply a small amount of the product up to four times daily, particularly after bowel movements or at , without exceeding the directed dosage unless advised by a doctor. As of 2025, Preparation H remains the number one doctor-recommended over-the-counter brand for relief based on clinical use and rankings.

Mechanism of Action

Preparation H primarily alleviates symptoms through the pharmacological actions of its active ingredients, which target vascular, neural, and inflammatory processes in the anorectal region. The core mechanism involves localized , , and effects, supplemented by protective agents that aid tissue recovery. These components work synergistically to reduce swelling, , and without systemic absorption in typical topical use. Phenylephrine hydrochloride, a key in many formulations, functions as an agonist that induces in the hemorrhoidal blood vessels. By narrowing these vessels, phenylephrine temporarily shrinks swollen tissue, decreases blood flow to the area, and thereby reduces engorgement and associated discomfort. This localized effect helps ease bowel movements and limits further irritation. Pramoxine hydrochloride provides rapid by reversibly binding to voltage-gated sodium channels on neuronal membranes, thereby inhibiting sodium influx and blocking the initiation and conduction of nerve impulses. This action numbs the anorectal tissues, effectively relieving sensations of pain, burning, and itching without affecting deeper nerve functions. In select formulations, such as the Soothing Relief Anti-Itch Cream, acts as a that binds to cytoplasmic receptors, translocating to the nucleus to inhibit pro-inflammatory transcription factors like and phospholipase A2. This suppresses the release of inflammatory mediators, cytokines, and prostaglandins, leading to decreased swelling, redness, and pruritus in the affected tissues. Petrolatum and , classified as protectants, form an occlusive barrier on the irritated and mucosa upon application. This semi-permeable layer lubricates the area, prevents loss, shields against irritants like stool, and promotes a moist environment that soothes discomfort and facilitates tissue repair.

Formulations

Topical Ointments and Creams

Preparation H offers several topical formulations in ointment and cream forms designed for external and limited internal application to alleviate symptoms such as itching, burning, pain, and swelling. The ointment variant is an oil-based product with a higher oil-to-water ratio, primarily composed of petrolatum (74.9%) and (14%) as protectants, along with HCl (0.25%) as a vasoconstrictor, which creates a greasy barrier to soothe and shield irritated skin. This formulation provides a protective coating that eases discomfort during bowel movements and promotes healing by reducing friction on affected areas. For external use, a dime-sized amount of the ointment is applied directly to the cleansed anorectal area using a clean finger, while internal application involves attaching the provided applicator to the tube, lubricating it, and gently inserting it into the lower before squeezing out the product. Cream variants, in contrast, are typically water-based or gel-like for quicker absorption and less residue compared to the ointment's thicker consistency. These creams target similar symptoms but incorporate additional soothing agents for enhanced comfort. The Maximum Strength Cream contains 0.25% HCl as a vasoconstrictor to shrink swollen tissue and 1% pramoxine HCl as a local for pain relief, alongside protectants like glycerin (14.4%) and white petrolatum (15%). The Multi-Symptom Pain Relief Cream builds on this by combining pain relief from pramoxine with tissue-shrinking effects from , while incorporating , , and for broad-spectrum soothing of burning, itching, and discomfort. Another option, the Rapid Relief with Lidocaine Cream, uses maximum-strength lidocaine for instant numbing alongside to address swelling and protect sensitive skin with ingredients like glycerin and white petrolatum. The Soothing Relief Anti-Itch Cream contains 1% to relieve itching. Application guidelines for both ointments and creams emphasize and moderation: first, cleanse the affected area by patting or blotting with a mild wipe or cloth, then apply a thin layer externally or to the lower up to four times daily, particularly after bowel movements, in the morning, and at night. For internal use with creams, a or the ointment's applicator may be employed similarly, though creams are primarily intended for external relief. All topical products should be stored at , between 20-25°C (68-77°F), away from excessive heat or moisture to maintain efficacy.

Suppositories and Other Inserts

Preparation H suppositories are rectal inserts formulated specifically for the relief of internal , offering targeted delivery of active ingredients to the affected area. These suppositories utilize a base that melts at body temperature, approximately 34–36°C, to provide , form a protective , and ease discomfort during bowel movements by reducing from stool contact. The primary in these suppositories is hydrochloride (0.25%), functioning as a vasoconstrictor to temporarily shrink swollen hemorrhoidal tissue and alleviate associated itching, burning, and . (88.44%) serves as the main protectant, comprising the bulk of the formulation to ensure smooth insertion and prolonged internal contact. Inactive components, such as , , and , support the suppository's structure and stability. For proper administration, users should cleanse and dry the rectal area before unwrapping the suppository by peeling back the foil tabs; the suppository is then held with the rounded end upward and inserted pointed end first into the , ideally about 1 inch deep in adults, using a finger. One suppository is recommended up to four times daily, particularly at to leverage extended-release effects during for sustained overnight relief of internal swelling and discomfort. Children under 12 should consult a physician before use. These suppositories are available over-the-counter in convenient tubes containing 12 or 24 units, allowing for easy storage at (20–25°C) and portable use as needed for ongoing management.

Wipes and Pads

Preparation H offers a range of medicated wipes and soothing pads designed for external cleansing and mild relief from hemorrhoidal irritation. These products are pre-moistened, disposable cloths intended for gentle in the anal area, helping to remove residue and soothe discomfort without harsh soaps. The standard Medicated Wipes contain 50% as an active ingredient, which provides temporary relief from itching, burning, and minor irritation associated with while aiding in the protection of sensitive anorectal skin. Inactive components often include for added soothing effects, along with water, glycerin, and to maintain moisture and pH balance; these wipes are alcohol-free, flushable when used one at a time, and septic-safe for convenient disposal. For more targeted numbing, the Rapid Relief Totables Wipes incorporate maximum-strength lidocaine (5%) as a local anesthetic to quickly alleviate pain, burning, and itching upon contact, combined with phenylephrine HCl (0.25%) as a vasoconstrictor and glycerin (20%) as a protectant; these portable, individually wrapped wipes are also alcohol-free and suitable for on-the-go use. Soothing Relief Cleansing & Cooling Wipes and Pads, featuring 20% and barbadensis leaf juice, emphasize cooling and calming post-bowel movement comfort by reducing and providing a fresh sensation without fragrances or parabens. These variants focus on everyday hygiene integration, with the pads often marketed for similar external application to cleanse and protect irritated areas. All Preparation H wipes and pads are for external use only, applied by gently wiping, patting, or blotting the affected area up to six times daily or after each bowel movement, and before other topical treatments; they should not be used internally or flushed in multiples to avoid plumbing issues. Children under 12 should consult a doctor before use. Packaging typically includes 48-count soft packs for home use or 20-count totable formats for portability, allowing seamless incorporation into daily routines for hygiene and mild symptom management. Specialized versions, such as Medicated Wipes for Women infused with , , and , offer additional cooling and soothing tailored to feminine needs.

Gels and Sprays

Preparation H also offers gels and sprays for targeted relief. The Cooling is a non-greasy containing and to cool burning and itching sensations. The Rapid Relief Spray with Lidocaine provides numbing relief for pain and irritation while reducing swelling, suitable for external use.

Ingredients

Active Ingredients

Preparation H formulations feature a variety of active ingredients that vary by product, including vasoconstrictors, local anesthetics, corticosteroids, and protectants such as petrolatum and glycerin. Preparation H formulations primarily feature HCl as the key in most United States-marketed ointments, creams, and suppositories, where it is included at a 0.25% concentration to serve as a vasoconstrictor that temporarily reduces swelling by constricting blood vessels in the affected area. This agent targets the vascular component of hemorrhoidal symptoms, providing relief from discomfort associated with tissue engorgement. In many formulations, protectants such as glycerin (14.4%), mineral oil (14%), and petrolatum (15-74.9%) are listed as active ingredients to soothe and protect the affected area by forming a barrier against irritation. Pramoxine HCl, at 1% concentration, is another core active component in multi-symptom relief products such as creams and ointments, functioning as a topical local to alleviate , burning, and itching sensations on the skin surface. It provides rapid numbing effects without penetrating deeply into tissues, making it suitable for external anorectal application. In anti-itch variants, such as the Soothing Relief Cream, is incorporated at 1% as a mild to diminish , redness, and pruritus by suppressing immune responses in the skin. This ingredient is specifically formulated for targeted itch relief and is available over-the-counter without a prescription . Certain products, such as the Rapid Relief Cream and Totables Wipes, include lidocaine at 5% as an active local anesthetic agent to deliver instant numbing for pain, burning, and itching. Historically, some international versions of Preparation H contained at 3% concentration as a protective and wound-healing agent, though it was banned by the FDA in for use in over-the-counter treatments in the United States due to insufficient of . This ingredient persists in select non-U.S. markets for its purported barrier-forming properties.

Inactive Ingredients and Regional Variations

Inactive ingredients in Preparation H products primarily serve as protectants, emollients, emulsifiers, and preservatives to provide a stable base, enhance application, and maintain product integrity. Common components include and petrolatum, which act as protectants to soothe and form a barrier against during bowel movements. Glycerin is frequently used for its moisturizing properties, helping to hydrate the affected area and prevent dryness. In suppository formulations, is a key base ingredient, comprising about 88.44% of the product to melt at body temperature and coat the rectal area for relief. Other supportive elements include and alcohols for emulsification and texture. Preservatives and stabilizers such as , , and help prevent microbial growth and oxidation, ensuring shelf life and safety. appears in some cream and wipe variants to aid solubility and stability. is incorporated in certain cleansing wipes as a . Formulations of Preparation H vary by region due to regulatory differences. In the United States, products exclude Biodyne (a yeast extract derived from ), which was removed in 1995 following FDA reclassification of certain ingredients as unapproved drugs. Canadian versions retain Biodyne in ointments and creams, often combined with hydrolyzed yeast for tissue support. Greek and some international formulations include 3% as an for its emollient and A-rich properties, alongside petrolatum and . In the United Kingdom, Preparation H products typically include cooling and soothing ingredients such as witch hazel (Hamamelis Virginiana Distillate) in gel formulations, and live yeast cell derivative (1% w/w) combined with shark liver oil (3% w/w) in ointments, without local anesthetics like pramoxine or significant steroids like hydrocortisone, differing from U.S. versions. Certain inactive ingredients may pose risks for allergic reactions in sensitive individuals. , present in many ointment bases, is a recognized contact that can cause , particularly on compromised skin. Parabens, used as preservatives in various products, have been associated with in some users, though reactions are uncommon. Users with known allergies to derivatives or preservatives should consult product labels or healthcare providers.

Safety and Precautions

Common Side Effects

Preparation H is generally well tolerated by most users, with the majority experiencing no adverse when used as directed. Mild at the application site represents the most frequently reported , often presenting as stinging, burning, or redness, particularly when applied to already inflamed or raw tissue. These symptoms are typically transient and subside with continued use or upon temporary cessation. Allergic responses occur in a small subset of individuals sensitive to specific components, such as the local pramoxine or certain preservatives, leading to symptoms like , localized swelling, or intensified itching. Such reactions are uncommon but warrant discontinuation and consultation with a healthcare provider if they persist or worsen. Systemic effects from Preparation H are rare due to limited absorption through rectal mucosa, though may occasionally cause mild elevations in , especially in those with predisposing factors. Overall, any reported side effects are mild, self-limiting, and resolve promptly after stopping the product.

Contraindications and Warnings

Preparation H is contraindicated in individuals with a known or to any of its ingredients, including hydrochloride or other components such as pramoxine HCl, , or petrolatum. Due to the vasoconstrictive effects of , the product should be avoided or used only under medical supervision in patients with heart disease, high , , , or difficulty urinating due to enlargement of the gland. The product is intended for external or rectal use only and must not be applied to the eyes, ingested orally, or inserted beyond the recommended depth using fingers or devices. Users should stop application and consult a healthcare provider if occurs, if the condition worsens or does not improve within 7 days, or if symptoms for which the product is being used persist or increase in severity. If swallowed, immediate medical attention is required. Regarding , use only if advised by a healthcare professional, as it is not known if rectal could affect or harm a . For individuals, consultation with a healthcare professional is recommended prior to use, as it is unknown whether is excreted in human milk. Drug interactions may occur with monoamine oxidase (MAO) inhibitors (such as isocarboxazid, linezolid, or phenelzine) or other sympathomimetic agents, potentially leading to hypertensive crisis or enhanced vasoconstrictive effects; concurrent use should be avoided. Patients taking prescription medications for high blood pressure or depression should consult a doctor or pharmacist before use. Certain formulations, such as medicated wipes containing combustible liquids, are flammable and should be kept away from heat, open flames, or smoking.

Marketing and Availability

Advertising and Branding

Preparation H's early advertising campaigns in the frequently utilized television commercials featuring emerging celebrities to promote its efficacy in providing rapid relief from hemorrhoidal symptoms. Actor , later known for roles in , appeared in a notable spot emphasizing the product's "oxygen action" formula, which was touted for shrinking swelling and soothing discomfort. These ads often highlighted quick-relief messaging, such as promises of prompt temporary relief from pain and itching, aligning with the era's direct approach to over-the-counter remedies. In more recent decades, Preparation H has shifted toward creative print and visual campaigns to address the stigma surrounding treatment. The "upside-down chairs" print ads depicted furniture with spiked legs to metaphorically illustrate the agony of sitting while afflicted, encouraging consumers to seek relief without explicit anatomical references. This campaign aimed to humanize the condition by focusing on everyday disruptions caused by discomfort. A significant occurred in with a effort led by design agency Elmwood, which introduced bold, humorous visuals to challenge societal taboos around "butt health." The refreshed identity incorporated playful elements like quirky typefaces and captions such as "Your butt is behind you no matter what," targeting a broader demographic while maintaining the brand's focus on comfort and confidence. This rebrand sought to Preparation H against competitors by leveraging wit to normalize discussions of hemorrhoidal issues. Complementing traditional media, Preparation H's includes interactive tools on its official website, such as the Relief Finder quiz, which guides users to personalized product recommendations based on symptoms. The brand consistently positions itself as the #1 doctor-recommended over-the-counter treatment in promotional materials, reinforcing trust through clinical endorsement claims. The product's cultural footprint extends to parodies in entertainment, notably a 2025 Saturday Night Live sketch featuring in a spoof commercial for "Flamin' Hot Preparation H," which humorously portrayed an ultra-spicy variant for post-snack relief, amplifying the brand's recognition through .

Global Distribution and Cultural Notes

Preparation H is widely available over-the-counter (OTC) in the United States at major pharmacies such as and , as well as through various online retailers. The brand generates annual sales exceeding $100 million in the U.S. market, with worldwide sales reaching $136 million in 2017, underscoring its dominant position in the hemorrhoidal treatment category. Internationally, Preparation H is accessible in , where the formulation includes the ingredient Biodyne (a ) to aid in tissue repair, differing from the U.S. version due to regulatory approvals. In , the product is sold in countries like , , and the , often reformulated to include natural components such as for moisturizing and anti-inflammatory effects; for instance, the Italian version contains 3% alongside yeast cell extract, while in the United Kingdom, formulations typically include cooling and soothing ingredients like witch hazel in the clear gel, and shark liver oil (3% w/w) with live yeast cell derivative (1% w/w) in the ointment, without local anesthetics or significant steroids. However, availability varies due to regional regulations; in the U.S., ingredients like were banned by the FDA in 1990 for lacking proven in , leading to reformulations not seen in some international markets. Restrictions or adaptations occur in other regions to comply with local health authority standards, ensuring the product meets safety and requirements without universal uniformity. Culturally, Preparation H has gained notoriety for in reducing under-eye wrinkles and puffiness, attributed to its vasoconstrictive properties that temporarily shrink blood vessels; this trend was popularized in 2018 media articles and anecdotes but is not recommended by the manufacturer due to risks of and lack of clinical for cosmetic benefits. The brand has actively addressed the societal stigma associated with hemorrhoidal conditions through marketing initiatives, such as the 2022 "Back There Care" campaign, which uses humor to normalize discussions of anal and encourage open conversations about symptoms often considered . As of 2025, Preparation H has expanded its presence through the official brand website, facilitating direct online purchases and subscriptions for convenient access amid growing digital retail trends in . No major supply shortages have been reported for the brand in key markets during this period.

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