Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Ammonium Lactate Cream, 12% is available as follows: 1-140 gram laminate tube NDC 51672-1301-2 2-140 gram laminate tubes NDC 51672-1301-4 385 gram plastic bottle NDC 51672-1301-0 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].; PRINCIPAL DISPLAY PANEL - 385 g Bottle Label NDC 51672-1301-4 Ammonium Lactate Cream 12%* carton-1
- HOW SUPPLIED Ammonium Lactate Cream, 12% is available as follows: 1-140 gram laminate tube NDC 51672-1301-2 2-140 gram laminate tubes NDC 51672-1301-4 385 gram plastic bottle NDC 51672-1301-0 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
- PRINCIPAL DISPLAY PANEL - 385 g Bottle Label NDC 51672-1301-4 Ammonium Lactate Cream 12%* carton-1
Overview
* Ammonium Lactate Cream, 12% specially formulates 12% lactic acid, as ammonium lactate to provide a cream pH of 4.5 to 5.5. Ammonium Lactate Cream, 12% also contains cetyl alcohol, glycerin, glyceryl monostearate, laureth-4, light mineral oil, magnesium aluminum silicate, methylcellulose, methylparaben, propylparaben, polyoxyethylene-100 stearate, polyoxyl 40 stearate, propylene glycol, purified water and for pH adjustment: lactic acid. Lactic acid is a racemic mixture of 2-hydroxypropanoic acid and has the following structural formula: Chemical Structure
Indications & Usage
Ammonium Lactate Cream, 12% is indicated for the treatment of ichthyosis vulgaris and xerosis.
Dosage & Administration
Apply to the affected areas and rub in thoroughly. Use twice daily or as directed by a physician.
Warnings & Precautions
WARNING Sun exposure to areas of the skin treated with Ammonium Lactate Cream, 12% should be minimized or avoided (see PRECAUTIONS section). The use of Ammonium Lactate Cream, 12% should be discontinued if any hypersensitivity is observed.
Contraindications
Ammonium Lactate Cream, 12% is contraindicated in those patients with a history of hypersensitivity to any of the label ingredients.
Adverse Reactions
In controlled clinical trials of patients with ichthyosis vulgaris, the most frequent adverse reactions in patients treated with Ammonium Lactate Cream, 12% were rash (including erythema and irritation) and burning/stinging. Each was reported in approximately 10 to 15% of patients. In addition, itching was reported in approximately 5% of patients. In controlled clinical trials of patients with xerosis, the most frequent adverse reactions in patients treated with Ammonium Lactate Cream, 12% were transient burning, in about 3% of patients, stinging, dry skin and rash, each reported in approximately 2% of patients.
Storage & Handling
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
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