Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Ammonium Lactate Lotion, 12% is available as follows: 225 g bottle (NDC 63629-8610-1) STORAGE Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].; Ammonium Lactate 12% Lotion, #225 Label
- HOW SUPPLIED Ammonium Lactate Lotion, 12% is available as follows: 225 g bottle (NDC 63629-8610-1) STORAGE Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].
- Ammonium Lactate 12% Lotion, #225 Label
Overview
*Ammonium Lactate Lotion, 12% specially formulates 12% lactic acid neutralized with ammonium hydroxide, as ammonium lactate to provide a lotion pH of 4.5 - 5.5. It also contains cetyl alcohol, fragrance, glycerin, glyceryl stearate, laureth-4, light mineral oil, magnesium aluminum silicate, methylcellulose, methylparaben, PEG-100 stearate, polyoxyl 40 stearate, propylene glycol, propylparaben, and purified water. Lactic acid is a racemic mixture of 2-hydroxypropanoic acid and has the following structural formula: structural formula
Indications & Usage
Ammonium Lactate Lotion, 12% is indicated for the treatment of dry, scaly skin (xerosis) and ichthyosis vulgaris, and for the temporary relief of itching associated with these conditions.
Dosage & Administration
Shake well. Apply to the affected areas and rub in thoroughly. Use twice daily or as directed by a physician.
Warnings & Precautions
WARNING Sun exposure (natural or artificial sunlight) to areas of the skin treated with Ammonium Lactate Lotion, 12% should be minimized or avoided (see PRECAUTIONS ). The use of Ammonium Lactate Lotion, 12% should be discontinued if any hypersensitivity is observed.
Contraindications
Ammonium Lactate Lotion, 12% is contraindicated in those patients with a history of hypersensitivity to any of the label ingredients.
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).
Similar Drugs
Related medications based on brand, generic name, substance, active ingredients.