RVP

Drug Catalog - Product Detail

AMMONIUM LACTATE LOTION LOT 0.12 400GM

NDC Mfr Size Str Form
45802-0419-26 PADAGIS 400 12% LOTION
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Generic Name
AMMONIUM LACTATE
Substance Name
AMMONIUM LACTATE
Product Type
HUMAN PRESCRIPTION DRUG
Route
TOPICAL
Application Number
ANDA075570
Description
DESCRIPTION *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
How Supplied
HOW SUPPLIED Ammonium Lactate Lotion, 12% is available as follows: 225 g bottle (NDC 45802- 419 -54) 400 g bottle (NDC 45802- 419 -26) STORAGE Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].
Indications & Usage
INDICATIONS AND 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 and Administration
DOSAGE AND ADMINISTRATION Shake well. Apply to the affected areas and rub in thoroughly. Use twice daily or as directed by a physician.