Ammonium Lactate
Ammonium Lactate is an FDA drug label for the active ingredient AMMONIUM LACTATE manufactured by A-S Medication Solutions administered by TOPICAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20230824.
Generic: AMMONIUM LACTATE
Manufacturer: A-S Medication Solutions
Product Type: HUMAN PRESCRIPTION DRUG
Route: TOPICAL
Dosage Form:
NDC: 50090-6587
Application: ANDA076216
Effective: 20230824
Indications & Usage
INDICATIONS AND USAGE Ammonium Lactate Lotion is indicated for the treatment of dry, scaly skin (xerosis) and ichthyosis vulgaris and for temporary relief of itching associated with these conditions.
Dosage & Administration
DOSAGE AND ADMINISTRATION Shake well. Apply to the affected areas and rub in thoroughly. Use twice daily or as directed by a physician.
Contraindications
CONTRAINDICATIONS Ammonium Lactate Lotion is contraindicated in those patients with a history of hypersensitivity to any of the label ingredients.
Warnings
WARNINGS Sun exposure to areas of the skin treated with Ammonium Lactate Lotion, 12% should be minimized or avoided (see PRECAUTIONS section). The use of Ammonium Lactate Lotion should be discontinued if hypersensitivity is observed.
Adverse Reactions
ADVERSE REACTIONS The most frequent adverse experiences in patients with xerosis are transient stinging (1 in 30 patients), burning (1 in 30 patients), erythema (1 in 50 patients) and peeling (1 in 60 patients). Other adverse reactions which occur less frequently are irritation, eczema, petechiae, dryness and hyperpigmentation. Due to the more severe initial skin conditions associated with ichthyosis, there was a higher incidence of transient stinging, burning and erythema (each occurring in 1 in 10 patients).
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