Drug Catalog - Product Detail
AMMONIUM LACTATE CREAM CRM 0.12 2X140GM
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 45802-0493-83 | PADAGIS | 140 | 12% | CREAM |
PACKAGE FILES
Generic Name
AMMONIUM LACTATE
Substance Name
AMMONIUM LACTATE
Product Type
HUMAN PRESCRIPTION DRUG
Route
TOPICAL
Application Number
ANDA075774
Description
DESCRIPTION *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
How Supplied
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 12-21
Indications & Usage
INDICATIONS AND USAGE Ammonium Lactate Cream, 12% is indicated for the treatment of ichthyosis vulgaris and xerosis.
Dosage and Administration
DOSAGE AND ADMINISTRATION Apply to the affected areas and rub in thoroughly. Use twice daily or as directed by a physician.