FDA-filed SPL labeling · retrieved through openFDA

Ammonium Lactate Topical

Ammonium lactate is a moisturizing skin treatment used to relieve dry, scaly skin and ichthyosis vulgaris, and to ease the itching that comes with these conditions.

Brand names Lac-HydrinGeri-HydrolacAmlactin
Drug class ⓘ Alpha-hydroxy Acid
Rx Form 1 Route Topical
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 12 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 effectiveJul 30, 2026
Clinical labels in scope ⓘ12
AvailabilityRx
Earliest approval/marketing year ⓘ1985
FDA-listed product records ⓘ27
Boxed warningNone found in compared labels
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 25, 2026
⭐ Ammonium Lactate Topical at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Ammonium lactate cream is a well-established moisturizing treatment for dry, scaly skin and ichthyosis vulgaris that works by helping skin retain moisture and shed built-up dead skin cells. It's generally well tolerated, though some stinging or redness is common at first. The biggest day-to-day precaution is protecting treated skin from the sun.

📖 Ammonium Lactate Topical: Patient Information Guide

A plain-language walkthrough of Ammonium Lactate Topical — 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▾

Ammonium lactate is a topical (applied to skin) moisturizing treatment approved for specific skin conditions. Supported uses include:

  • Xerosis — dry, rough, scaly skin: Ammonium Lactate Cream, 12% helps restore moisture and improve skin texture.
  • Ichthyosis vulgaris — an inherited condition causing persistent, fish-scale-like skin scaling: Ammonium Lactate Cream, 12% helps reduce scaling.
  • Itching relief — temporary relief of itching associated with xerosis and ichthyosis vulgaris.
⚙️How it works▾

Lactic acid is an alpha-hydroxy acid — a type of naturally occurring acid found in the body. When applied to skin, it works as a humectant, drawing moisture into the outermost skin layer (the stratum corneum) to keep it hydrated and supple. It also appears to reduce the stickiness between dead skin cells, helping them shed more normally and reducing the buildup that causes scaling — though the exact process behind this is still being studied.

💊How it's taken▾

Apply ammonium lactate cream to the affected skin areas and rub in thoroughly. It is typically used twice a day, or as your doctor directs. If you are using the lotion form, shake it well before applying. There is no food timing requirement for a topical product. Follow your prescriber's specific instructions — they may adjust how often you apply it based on how your skin responds.

🤒Side effects — in detail▾

Most side effects from ammonium lactate cream are mild and occur right at the application site. Common reactions include:

  • Burning or stinging (most common, especially at first)
  • Skin irritation or redness
  • Rash
  • Itching
  • Dry skin

If you develop a significant rash, severe irritation, or signs of an allergic reaction (like worsening redness, swelling, or hives), stop using the product and contact your doctor right away.

⚠️Warnings & precautions▾

Sun sensitivity is the key warning. Skin treated with ammonium lactate cream should not be exposed to sunlight (or artificial UV light like tanning beds) more than necessary. The treated areas can react more strongly to UV rays, increasing the risk of irritation or sunburn.

Stop using the product immediately if you notice any signs of an allergic reaction, such as a new or worsening rash, significant redness, or skin that is clearly getting worse rather than better.

🔀What it interacts with▾

The label does not identify specific drug or food interactions for ammonium lactate cream.

    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▾
    • Allergy to ingredients: Do not use ammonium lactate if you have had an allergic reaction to any component of the product in the past.
    • Sun exposure: Let your doctor know if you spend significant time outdoors or use tanning beds — you will need to be especially careful to protect treated skin from UV light.
    🚑If you take too much▾

    Because ammonium lactate is applied to the skin rather than swallowed, accidental overdose through normal use is not a practical concern. Animal studies using very large oral (swallowed) amounts showed the product to be essentially non-toxic.

    📡Pharmacodynamics — effects in the body▾

    Ammonium lactate cream works directly on the skin's surface. It helps the outer skin layer (stratum corneum) hold onto more water, improving hydration and making dry, rough skin feel softer. It also appears to reduce the cohesion — or stickiness — between dead skin cells, which helps normalize the shedding process and reduce visible scaling in conditions like ichthyosis vulgaris and xerosis.

    🔬Pharmacokinetics — how your body processes it▾

    Ammonium lactate is absorbed through the skin to a limited extent. An in vitro (laboratory) study using human cadaver skin found that approximately 6.1% of the applied ammonium lactate cream was absorbed after 68 hours, suggesting most of it stays at the skin surface where it is needed.

    📦How to store it▾

    Store between 20° to 25°C (68° to 77°F) .

    📄 Written from Ammonium Lactate Topical’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 Ammonium Lactate Topical — the kind of thing our pharmacy team would talk through with you at the counter.

    What exactly is ammonium lactate cream used for? ▾
    It's used to treat dry, scaly skin — medically called xerosis — and a condition called ichthyosis vulgaris, which causes the skin to form thick, fish-scale-like patches. It also helps with the itching that often comes with both of these conditions. Think of it as a medicated moisturizer that works a bit more aggressively than an over-the-counter lotion.
    How do I apply it and how often should I use it? ▾
    Apply it directly to the dry or scaly areas of your skin and rub it in well. The typical direction is twice a day — morning and evening works for most people — unless your doctor tells you otherwise. If you're using the lotion version, give it a good shake before applying. Consistency matters with this kind of product, so try not to skip applications.
    Will it burn or sting when I put it on? ▾
    Honestly, yes — burning or stinging right after you apply it is pretty common, especially in the first few days of use. In clinical trials, about 10 to 15% of people using it for ichthyosis vulgaris reported this, and about 3% of those treating dry skin noticed it too. For most people it settles down as the skin adjusts. If the burning is severe or your skin gets significantly worse rather than better, though, check in with your doctor.
    Do I need to worry about going out in the sun while using this? ▾
    Yes — this is probably the biggest day-to-day thing to keep in mind. Ammonium lactate cream can make treated skin more sensitive to sunlight and artificial UV light like tanning beds. Try to cover up or stay out of the sun when you can on the areas where you've applied it. If sun exposure is unavoidable, talk to your doctor about the best way to protect your skin.
    Can I have an allergic reaction to this cream? ▾
    It's possible, though not common. If you notice significant redness, swelling, hives, or a rash that seems to be getting worse rather than better after using it, stop applying the cream right away and call your doctor. If you've had a reaction to any ingredient in this type of product before, let your doctor know before you start using it — it may not be right for you.
    How long does it take to start working? ▾
    The label doesn't spell out an exact timeline, and results can vary from person to person. With moisturizing treatments like this one, many people notice some improvement in skin texture and comfort within a few weeks of consistent use. Give it time and stick with the twice-daily routine — and if you're not seeing any change after several weeks, it's worth checking back with your doctor.
    Is Ammonium Lactate Topical available over the counter? ▾
    Ammonium Lactate Topical is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
    When was Ammonium Lactate Topical first available? ▾
    Ammonium Lactate Topical has been available in the United States since at least 1985, based on FDA approval history (Drugs@FDA) and product marketing records.
    Who makes Ammonium Lactate Topical? ▾
    Ammonium Lactate Topical is supplied by 6 manufacturers listed in the FDA NDC Directory, including Bryant Ranch Prepack, Padagis Israel Pharmaceuticals Ltd, Sun Pharmaceutical Industries, Inc..

    💬 Answers drafted from Ammonium Lactate Topical’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

    💊 How Ammonium Lactate Topical comes

    Ammonium Lactate Topical is available in 1 form. 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
    How this form is used
    What it may be used for
    • Ammonium Lactate Cream, 12% treats dry, scaly skin (xerosis)
    • Ammonium Lactate Cream, 12% treats ichthyosis vulgaris (an inherited scaling skin condition)
    • Ammonium Lactate Cream, 12% temporarily relieves itching associated with these conditions
    Important instructions
    • Ammonium Lactate: apply to affected skin areas and rub in thoroughly
    • Ammonium Lactate: use twice daily or as directed by your doctor
    • Ammonium Lactate: shake the lotion form well before each use
    • Ammonium Lactate: minimize or avoid sun exposure on treated skin areas while using this product
    Available strengths 2 strengths
    27 FDA-listed product records ⓘ

    📊 Ammonium Lactate Topical across the U.S. market

    How Ammonium Lactate Topical 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.

    1
    Dose forms ⓘ
    6
    Manufacturers
    1
    Brand names
    27
    FDA-listed product records ⓘ
    1985
    First marketed ⓘ
    Bryant Ranch Prepack41%
    Padagis Israel Pharmaceuticals Ltd22%
    Sun Pharmaceutical Industries, Inc.15%
    Taro Pharmaceuticals U.S.A., Inc.11%
    Remedyrepack Inc.7%
    A-S Medication Solutions4%

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

    📈 How widely Ammonium Lactate Topical is used

    A general measure of how commonly Ammonium Lactate Topical 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 Ammonium Lactate Topical 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.

    263,246
    Medicaid prescriptions filled (Q1–Q4 2025)
    $5.2M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

    How commonly is Ammonium Lactate Topical prescribed? Of the 1,597 medications we measure, Ammonium Lactate Topical ranks #342 by Medicaid prescriptions — more than 79% of them.

    Where Ammonium Lactate Topical ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

    Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Ammonium Lactate Topical, 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 8 of 20 listed Ammonium Lactate Topical NDCs with Medicaid activity.

    🔍 Compare Ammonium Lactate Topical products

    A representative set of FDA-listed product records for Ammonium Lactate Topical — 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.)

    Strength Route Manufacturer / Labeler Category ⓘ Details
    💊Topical cream, ointment or gel
    120 mg/g Topical A-S Medication Solutions ANDA View NDC →
    12 g/100 g Topical Bryant Ranch Prepack × 11 listings ANDA View NDC →
    12 g/100 g Topical Padagis Israel Pharmaceuticals Ltd × 6 listings ANDA View NDC →
    120 mg/g Topical Remedyrepack Inc. × 2 listings ANDA View NDC →
    120 mg/g Topical Sun Pharmaceutical Industries, Inc. × 4 listings ANDA View NDC →
    120 mg/g Topical Taro Pharmaceuticals U.S.A., Inc. × 3 listings ANDA View NDC →

    Showing 27 of 27 products — FDA National Drug Code Directory. See every product, package size and price: browse all 27 Ammonium Lactate Topical NDCs →

    🏷️ Sold under these brand names

    Lac-Hydrin Geri-Hydrolac Amlactin

    🏭 Manufacturers & labelers

    Bryant Ranch Prepack 11 Padagis Israel Pharmaceuticals Ltd 6 Sun Pharmaceutical Industries, Inc. 4 Taro Pharmaceuticals U.S.A., Inc. 3 Remedyrepack Inc. 2 A-S Medication Solutions 1

    RxNorm drug class

    Ammonium Lactate Topical belongs to the Organic acids class.

    Drug family (ATC) Organic acids
    How it works Acidifying Activity

    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 Jul 30, 2026
    🏭
    Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Ammonium Lactate Topical.
    📈
    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 Ammonium Lactate Topical after exact ingredient or ingredient-combination matching and applicable route/form matching
    Clinical labels in scope
    12
    NDC products indexed
    27
    Distinct labelers/manufacturers represented
    6
    Linked representative label ⓘ
    Taro Pharmaceuticals U.S.A., Inc.
    Linked label effective
    Jul 30, 2026
    Composite sections available
    15
    Linked SPL Set ID
    8bb09bb3-5bbc-489d-96c1-ae97cb58381e
    Linked SPL Document ID
    57d7e3ba-2c3e-a79b-e063-6394a90a4a5b
    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 12 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.

    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. Taro Pharmaceuticals U.S.A., Inc. 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.