Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Ammonium Lactate Cream, 12% is available as follows: 385 g bottle (NDC 45802- 493 -26) 280 g carton (NDC 45802- 493 -83) containing two 140 g tubes (NDC 45802- 493 -98) STORAGE Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Manufactured by Padagis Minneapolis, MN 55427 www.padagis.com Rev 06-25 99R97 RC F4; Principal Display Panel NDC 45802-493-26 Rx Only Ammonium Lactate Cream, 12% For Dermatologic Use Only Not for Ophthalmic, Oral or Intravaginal Use Keep out of the reach of children NET WT 385 g Label
- HOW SUPPLIED Ammonium Lactate Cream, 12% is available as follows: 385 g bottle (NDC 45802- 493 -26) 280 g carton (NDC 45802- 493 -83) containing two 140 g tubes (NDC 45802- 493 -98) STORAGE Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Manufactured by Padagis Minneapolis, MN 55427 www.padagis.com Rev 06-25 99R97 RC F4
- Principal Display Panel NDC 45802-493-26 Rx Only Ammonium Lactate Cream, 12% For Dermatologic Use Only Not for Ophthalmic, Oral or Intravaginal Use Keep out of the reach of children NET WT 385 g Label
Overview
*Ammonium Lactate Cream, 12% is a formulation of 12% lactic acid neutralized with ammonium hydroxide, as ammonium lactate with a pH of 4.4 - 5.4. Ammonium Lactate Cream, 12% also contains cetyl alcohol, 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: Ammonium Lactate Cream Structural Formula
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 Use of this product should be discontinued if hypersensitivity to any of the ingredients is noted. Sun exposure to areas of the skin treated with ammonium lactate cream should be minimized or avoided (see PRECAUTIONS ).
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 were rash (including erythema and irritation) and burning/stinging. Each was reported in approximately 10-15% 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 were transient burning, in about 3% of patients, stinging, dry skin and rash, each reported in approximately 2% of patients.
Storage & Handling
STORAGE Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Manufactured by Padagis Minneapolis, MN 55427 www.padagis.com Rev 06-25 99R97 RC F4
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