FDA-filed SPL labeling · retrieved through openFDA

Pramoxine

Pramoxine is a topical local anesthetic used across many products to temporarily relieve pain and itching from minor skin irritations, insect bites, burns, rashes, and more.

Brand names Fleet Pain-ReliefItch-XPrameGelPraxTronolane +11 more
OTC Forms 4 Routes Topical · Rectal
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 31 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveDec 12, 2024
Clinical labels in scope ⓘ31
AvailabilityOTC
Earliest approval/marketing year ⓘ1973
FDA-listed product records ⓘ76
Boxed warningNone found in compared labels
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 21, 2026
⭐ Pramoxine at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Pramoxine is a widely available topical anesthetic that provides temporary relief from pain and itching due to minor skin irritations, insect bites, burns, and rashes. Use it only on the outside of the skin, follow your product's directions for how often to apply, and stop use and call a doctor if symptoms worsen or don't improve within 7 days. It's not a substitute for treating the underlying cause of a rash or skin problem.
How we write & review this content — our editorial policy →

📖 Pramoxine: Patient Information Guide

A plain-language walkthrough of Pramoxine — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for▾

Pramoxine is a topical anesthetic (numbing medicine applied to the skin) found in many over-the-counter products for temporary relief of pain and itching. Here is the full range of supported uses across these products:

  • Minor skin irritations (supported by most products)
  • Insect bites (CVS Anti-Itch, First Degree Maximum Strength Burn, Licefreee AfterLice, Anti Itch Soothing 1 Pramoxine Hydrochloride, and others)
  • Minor burns and sunburn (CVS Anti-Itch, First Degree Maximum Strength Burn, and other lotion/cream products)
  • Minor cuts and scrapes (CVS Anti-Itch, First Degree Maximum Strength Burn, and related products)
  • Rashes from poison ivy, poison oak, and poison sumac — including drying oozing and weeping (CVS Anti-Itch and related lotion products; Ivarest Poison Ivy Removal and Itch Relief)
  • Fever blisters and cold sores — Curasore topical liquid only
  • Minor external vaginal irritation — Terramed Just Think Comfort GynoCare BV Guard Intimate Wash only
  • External genital itching and irritation — Terramed Just Think Comfort HerpCare Intimate Wash only
  • External rectal/anal area pain and itching — Proctofoam foam only
  • Post-shaving or grooming sensitivity and dry skin itch (Numbing cream products)
💊How it's taken▾

Pramoxine is applied directly to the skin or affected external area — never taken by mouth or used inside the vagina. Frequency varies by product:

  • Most topical creams, sprays, and solutions: up to 3 to 4 times daily
  • Anorectal products (such as Proctofoam) and some lotion formulations: up to 5 times daily for adults
  • Genital wash products (Terramed GynoCare BV Guard Intimate Wash, HerpCare Intimate Wash): once or twice daily

When practical, gently clean and dry the affected area before applying. Follow the specific directions on your product label and your prescriber's guidance, as instructions differ between products and age groups.

🤒Side effects — in detail▾

The FDA product labels for pramoxine do not list common side effects specifically. However, the warnings indicate that skin irritation can sometimes worsen after use.

  • Worsening irritation or redness at the application site — stop use if this happens
  • Allergic reaction (rash, itching, swelling) — stop use and seek medical attention

If any unusual reaction develops after applying pramoxine, stop using the product and contact a doctor right away.

⚠️Warnings & precautions▾
  • External use only: Never use pramoxine inside the vagina or allow it to get in your eyes. If eye contact occurs, rinse thoroughly with water.
  • Do not apply to open wounds or broken skin unless directed by a doctor.
  • Stop use and see a doctor if symptoms worsen, last more than 7 days, or clear up and quickly return.
  • Genital area products: Stop use if you develop unusual vaginal discharge, fever, foul odor, or pelvic pain — these may signal a condition that needs medical treatment.
  • Allergic reactions: If a new rash or reaction develops after use, stop immediately and contact a doctor.
  • Children: Most products should not be used in children under 2 without a doctor's guidance; some products require a doctor for children under 12.
  • If swallowed: Call Poison Control at 1-800-222-1222 right away or get emergency help.
🔀What it interacts with▾

The FDA product labels for pramoxine do not identify specific drug, food, or supplement interactions.

    This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

    📋Before taking it▾
    • Tell your doctor if you are pregnant or breastfeeding before using any pramoxine product.
    • Most products are not recommended for children under 2 years of age without a doctor's approval.
    • Anorectal and certain lotion formulations require a doctor's consultation for children under 12.
    • The Terramed GynoCare BV Guard Intimate Wash is intended for adult women 18 years and older only.
    • Keep all pramoxine products out of reach of children at all times.
    🚑If you take too much▾

    If pramoxine is swallowed, call Poison Control immediately at 1-800-222-1222, or go to the nearest emergency room. Keep all products stored safely out of children's reach to prevent accidental ingestion.

    📦How to store it▾

    Store at 20°C to 25°C (68°F to 77°F)

    📄 Written from Pramoxine’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

    🩺 Pharmacist Counseling Corner

    Quick, plain-English answers to the questions patients ask most about Pramoxine — the kind of thing our pharmacy team would talk through with you at the counter.

    What exactly does pramoxine do — how does it stop the itching? ▾
    Pramoxine is a local anesthetic, which means it temporarily numbs the area where you apply it. It works right at the skin's surface to block the sensation of pain and itching. It doesn't treat whatever is causing the itch — it just gives you relief while your skin heals. That's why it's described as 'temporary' relief on all the product labels.
    How many times a day can I use this? ▾
    It depends on which product you have. Most creams, sprays, and solutions are used up to 3 to 4 times daily. Some products, like Proctofoam for the rectal area, can be used up to 5 times daily for adults. Genital wash products like the Terramed GynoCare Intimate Wash are used once or twice a day. Always follow the directions on your specific product — more is not better and can irritate your skin.
    Can I use pramoxine inside the vagina or rectum? ▾
    No. All pramoxine products are for external use only — that means the outside of the skin. Even products intended for the genital or rectal area, like the Terramed Intimate Wash or Proctofoam, are applied only to the external skin surface. Never insert any product inside the vagina or rectum unless a doctor specifically tells you to.
    I've been using it for a week and the itch is still there — should I keep going? ▾
    Seven days is the limit before you should check in with a doctor. If your symptoms haven't improved after 7 days, or they get worse at any point, stop using the product and call your doctor. The same goes if symptoms go away and then come back quickly — that pattern can mean something else is going on that needs proper treatment.
    Is it safe to use during pregnancy or while breastfeeding? ▾
    The labels say to ask a doctor before using any pramoxine product if you're pregnant or breastfeeding. It's a brief conversation worth having — your doctor can tell you whether it's appropriate for your situation and which product, if any, makes the most sense to use.
    Can my child use this? ▾
    It depends on the product and your child's age. For most pramoxine creams and solutions, children under 2 years old should not use the product without a doctor's approval. Some products, like Proctofoam, require a doctor's consultation for anyone under 12. Always check the label of your specific product for the age guidance, and when in doubt, call your pediatrician.
    Is Pramoxine available over the counter? ▾
    Yes — Pramoxine is available over the counter (without a prescription) in at least some forms, according to its FDA labeling. Follow the package directions and ask your pharmacist if you're unsure which product is right for you.
    When was Pramoxine first available? ▾
    Pramoxine has been available in the United States since at least 1973, based on FDA approval history (Drugs@FDA) and product marketing records.
    Who makes Pramoxine? ▾
    Pramoxine is supplied by 41 manufacturers listed in the FDA NDC Directory, including The Honey Pot Company LLC, L'Oreal USA Products Inc, Combe Incorporated.

    💬 Answers drafted from Pramoxine’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

    🧰 Keep exploring

    🌿Drug & Supplement CheckerPramoxine vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Pramoxine NDCs & costs 🅰️Browse Drugs A–ZLook up any medication

    💊 How Pramoxine comes

    Pramoxine is available in 4 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

    Topical cream, ointment or gel

    On the skin
    Brands Anti-Itch Soothing Wipes 1 Pramoxine Hydrochloride Prax VAGISIL Anti-Itch Medicated Wipes Maximum Strength Walgreen Anti-Itch
    How this form is used
    What it may be used for
    • CVS Anti-Itch: temporary relief of pain and itching from insect bites, minor burns, sunburn, minor skin irritations, minor cuts, scrapes, and rashes from poison ivy, poison oak, and poison sumac
    • First Degree Maximum Strength Burn: temporary relief of pain and itching from minor burns, insect bites, sunburns, minor cuts, scrapes, and minor skin irritations
    • Aveeno Calm Plus Restore Itch Relief Balm and Aveeno Restorative Skin Therapy Itch Relief Balm: temporary relief of itching from minor skin irritations
    • CeraVe Developed with Dermatologists Itch Relief Moisturizing: temporary relief of itching from minor skin irritations
    Important instructions
    • First Degree Maximum Strength Burn: clean the affected area, then apply up to 3 to 4 times daily for adults and children 2 years and older; may be covered with a sterile bandage
    • First Degree Maximum Strength Burn: children under 2 years of age — ask a doctor before use
    • CVS Anti-Itch: apply to affected area as directed; for external use only
    Available strengths 9 strengths
    1 mg/mL 5 mg/g 0.01 g/g 10 mg 10 mg/g 10 mg/mL
    Show 3 more strengths Show fewer strengths
    0.9 g/90 mL 1 g/100 g 1 g/100 mL
    51 FDA-listed product records ⓘ

    Topical spray

    On the skin
    Brands Anti Itch Soothing 1 Pramoxine Hydrochloride
    How this form is used
    What it may be used for
    • Anti Itch Soothing 1 Pramoxine Hydrochloride: temporary relief of pain and itching from minor skin irritations
    • Licefreee AfterLice: temporary relief of itching from insect bites and minor skin irritations
    Important instructions
    • Anti Itch Soothing 1 Pramoxine Hydrochloride: apply to affected area as directed on product label; for external use only
    • Licefreee AfterLice: apply to affected area as directed on product label; for external use only
    Available strengths 2 strengths
    10 mg/g 10 mg/mL
    7 FDA-listed product records ⓘ

    Topical solution

    On the skin
    Brands Curasore
    How this form is used
    What it may be used for
    • Curasore: temporary relief of pain and itching from fever blisters and cold sores
    • Ivarest Poison Ivy Removal and Itch Relief: temporary relief of pain and itching from rashes due to poison ivy, poison oak, or poison sumac
    • Terramed Just Think Comfort GynoCare BV Guard Intimate Wash: temporary relief of pain, itching, and burning from minor external vaginal irritation and minor skin discomfort in the external genital area
    • Terramed Just Think Comfort HerpCare Intimate Wash: temporary relief of itching and irritation in the external genital area
    Important instructions
    • Curasore: apply to affected area not more than 3 to 4 times daily for adults and children 2 years and older; avoid moistening the area for 2 to 3 minutes after applying; children under 2 years — consult a doctor
    • Terramed Just Think Comfort GynoCare BV Guard Intimate Wash: wet external vaginal area with warm water, dispense a small amount, gently cleanse externally only, leave on 30–60 seconds, rinse thoroughly, pat dry; use once or twice daily for adult women 18 and older
    • Terramed Just Think Comfort HerpCare Intimate Wash: wash hands before and after use; wet the external genital area, apply a small amount, leave on briefly, rinse thoroughly and pat dry; use once or twice daily for adults and children 12 and older; children under 12 — ask a doctor
    Available strengths 2 strengths
    10 mg/mL 1 g/100 mL
    5 FDA-listed product records ⓘ

    Inhaler

    On the skin · Rectal
    Brands Proctofoam
    How this form is used
    What it may be used for
    • Proctofoam: temporary relief of pain and itching in the external rectal/anal area
    Important instructions
    • Proctofoam: place cap on container and shake well before each use
    • Proctofoam: when practical, gently cleanse the affected area with mild soap and warm water, rinse, and pat dry before applying
    • Proctofoam: dispense foam onto a clean tissue and apply externally to the affected area — up to 5 times daily for adults
    • Proctofoam: children under 12 years of age should not use without consulting a physician
    Available strengths 2 strengths
    10 mg/g 150 mg/15 g
    3 FDA-listed product records ⓘ

    📊 Pramoxine across the U.S. market

    How Pramoxine appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

    4
    Dose forms ⓘ
    41
    Manufacturers
    35
    Brand names
    76
    FDA-listed product records ⓘ
    1973
    First marketed ⓘ

    FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

    Also listed with the FDA, not a patient dose form: Powder (10) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

    The Honey Pot Company LLC9%
    L'Oreal USA Products Inc8%
    Combe Incorporated5%
    Cvs5%
    Ferndale Laboratories, Inc.5%
    Walgreens4%
    Other makers63%

    Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

    📈 How widely Pramoxine is used

    A general measure of how commonly Pramoxine is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

    Think of this as a proxy for how widely Pramoxine is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

    79
    Medicaid prescriptions filled (Q1–Q4 2025)
    $6,178 gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

    How commonly is Pramoxine prescribed? Of the 1,596 medications we measure, Pramoxine ranks #1,518 by Medicaid prescriptions — more than 5% of them.

    Where Pramoxine ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
    Total prescriptions — #1,518 of 1,596
    #1,513 Temsirolimus 86 Rx #1,514 Pralatrexate Injection 86 Rx #1,515 Inotuzumab Ozogamicin... 85 Rx #1,516 Meclofenamate 85 Rx #1,517 Lansoprazole, Clarithr... 84 Rx #1,518 Oritavancin Injection 79 Rx #1,519 Pramoxine 79 Rx #1,520 Cetirizine Ophthalmic 76 Rx #1,521 Mitomycin 76 Rx #1,522 Avapritinib 73 Rx #1,523 Teplizumab-mzwv inject... 73 Rx

    Utilization by Pramoxine product

    Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

    The 10 mg/mL rectal foam is the most-dispensed Pramoxine product — about 71% of these Medicaid prescriptions.

    pramoxine hydrochloride 10 MG/ML Rectal Foam Most dispensed

    56 Medicaid prescriptions (Q1–Q4 2025) 71% of Pramoxine prescriptions shown $5,991 gross reimbursement (before rebates) ≈ $107 per prescription (gross)

    Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 828365

    pramoxine hydrochloride 10 MG/ML Topical Lotion

    23 Medicaid prescriptions (Q1–Q4 2025) 29% of Pramoxine prescriptions shown $187 gross reimbursement (before rebates) ≈ $8.11 per prescription (gross)

    Summed across the 1 of 21 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1246075

    Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

    Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Pramoxine, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 2 of 23 listed Pramoxine NDCs with Medicaid activity.

    🔍 Compare Pramoxine products

    A representative set of FDA-listed product records for Pramoxine — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

    Showing 76 of 76 products — FDA National Drug Code Directory. See every product, package size and price: browse all 76 Pramoxine NDCs →

    RxNorm Concept Web — From Ingredient to Every Form and Strength

    This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

    Ingredient (IN) Pramoxine RxCUI 34347 11 dose forms · 12 strengths
    1. Dose form (SCDF) Medicated Liquid Soap RxCUI 1247250 In current FDA listings
      Clinical drug / strength (SCD) hydrochloride 10 MG/ML RxCUI 1247251
    2. Dose form (SCDF) Medicated Pad RxCUI 824280 No current FDA listing
      Clinical drug / strength (SCD) hydrochloride 10 MG/ML RxCUI 1039541
    3. Dose form (SCDF) Medicated Shampoo RxCUI 1092621 In current FDA listings
      Clinical drug / strength (SCD) hydrochloride 10 MG/ML RxCUI 1244963
    4. Dose form (SCDF) Rectal Foam RxCUI 384612 No current FDA listing
      Clinical drug / strength (SCD) hydrochloride 10 MG/ML RxCUI 828365
    6. Dose form (SCDF) Topical Foam RxCUI 2539964 In current FDA listings
      Clinical drug / strength (SCD) hydrochloride 10 MG/ML RxCUI 2539965
    7. Dose form (SCDF) Topical Gel RxCUI 378009 In current FDA listings
      Clinical drug / strength (SCD) hydrochloride 0.01 MG/MG RxCUI 1294026
    8. Dose form (SCDF) Topical Lotion RxCUI 377924 In current FDA listings
      Clinical drug / strength (SCD) hydrochloride 10 MG/ML RxCUI 1246075
    9. Dose form (SCDF) Topical Ointment RxCUI 452815 In current FDA listings
      Clinical drug / strength (SCD) hydrochloride 0.01 MG/MG RxCUI 1294027
    10. Dose form (SCDF) Topical Solution RxCUI 375242 In current FDA listings
      Clinical drug / strength (SCD) hydrochloride 10 MG/ML RxCUI 1294034
    11. Dose form (SCDF) Topical Spray RxCUI 379492 In current FDA listings
      Clinical drug / strength (SCD) hydrochloride 10 MG/ML RxCUI 1294036

    Look up RxCUI 34347 in the RxCUI Atlas →

    RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

    🏷️ Sold under these brand names

    Fleet Pain-Relief Itch-X PrameGel Prax Tronolane Vagisil Wipes Eczemin Summers Eve Anti-Itch New-Skin Poison Ivy Dermal-Soothe Curasore Proctofoam Anti-Itch Soothing Wipes 1 Pramoxine Hydrochloride VAGISIL Anti-Itch Medicated Wipes Maximum Strength Walgreen Anti-Itch Anti Itch Soothing 1 Pramoxine Hydrochloride

    🏭 Manufacturers & labelers

    The Honey Pot Company LLC 7 L'Oreal USA Products Inc 6 Combe Incorporated 4 Cvs 4 Ferndale Laboratories, Inc. 4 Walgreens 3 Rida LLC 3 Crown Laboratories 3 Johnson & Johnson Consumer Inc. 3 AvPAK 2 Tec Laboratories Inc. 2 S.S.S. Company 2 Nuvothera, Inc. 2 Kenvue Brands LLC 2 Chain Drug Market Association 2 Cardinal Health, 110 dba Leader 2 Welmedix LLC 1 Flowchem Pharma Private Limited 1 Alyk, Inc. 1 W. R. Grace & Co.-conn. 1 Viatris Specialty LLC 1 Blistex Inc. 1 Bloomwell Gardens Llc 1 Syn-Tech Chem. & Pharm. Co., Ltd. 1

    …and 16 more on the FDA NDC directory.

    RxNorm drug class

    Pramoxine belongs to the Local anesthetics class.

    Drug family (ATC) Local anesthetics, Anesthetics for topical use

    Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

    🔬 Where this comes from

    Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

    📄
    FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Dec 12, 2024
    🏭
    Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Pramoxine.
    📈
    Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
    🚨
    Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
    🧾 Clinical label set — FDA-filed SPL labels retained for Pramoxine after exact ingredient or ingredient-combination matching and applicable route/form matching
    Clinical labels in scope
    31
    NDC products indexed
    76
    Distinct labelers/manufacturers represented
    41
    Linked representative label ⓘ
    Combe Incorporated
    Linked label effective
    Dec 12, 2024
    Composite sections available
    7
    Linked SPL Set ID
    b848f53d-8aea-4efe-aa2c-009d5121fc33
    Linked SPL Document ID
    d52bff6a-9386-4ff7-a2ff-bef4a6ad07f8
    Open the linked representative label on DailyMed ↗

    How we combine label and product data

    HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 31 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

    For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Combe Incorporated is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

    This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.