Drug Catalog - Product Detail
AZELAIC ACID GEL 15% 50GM
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00781-7172-50 | SANDOZ | 50 | 15% | GEL |
PACKAGE FILES
Generic Name
AZELAIC ACID
Substance Name
AZELAIC ACID
Product Type
HUMAN PRESCRIPTION DRUG
Route
TOPICAL
Application Number
NDA021470
Description
11 DESCRIPTION Azelaic acid gel, 15%, is an aqueous gel which contains azelaic acid, a naturally-occurring saturated dicarboxylic acid. It is for topical use. Chemically, azelaic acid is 1,7-heptanedicarboxylic acid. The molecular formula for azelaic acid is C 9 H 16 O 4 . It has the following structure: Azelaic acid has a molecular weight of 188.22. It is a white, odorless crystalline solid. It is poorly soluble in water at 20°C (0.24%) but freely soluble in boiling water and in ethanol. Azelaic acid gel, 15% is a white to yellowish white opaque gel for topical use; each gram contains 0.15 gm azelaic acid (15% w/w) in an aqueous gel base containing benzoic acid (as a preservative), disodium EDTA, lecithin, medium-chain triglycerides, polyacrylic acid, polysorbate 80, propylene glycol, purified water, and sodium hydroxide to adjust pH. Chemical Structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Azelaic acid gel, 15% is a white to yellowish white opaque gel supplied in a 50 g tube (NDC 0781-7172-50). Storage and Handling Store at 25°C (77°F); excursions permitted between 15-30°C (59-86°F) [see USP Controlled Room Temperature].
Indications & Usage
1 INDICATIONS AND USAGE Azelaic acid gel, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea. Azelaic acid gel, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea ( 1 ). Limitations of Use Efficacy for treatment of erythema in rosacea in the absence of papules and pustules has not been evaluated. ( 1 ) Limitations of Use Although some reduction of erythema which was present in patients with papules and pustules of rosacea occurred in clinical studies, efficacy for treatment of erythema in rosacea in the absence of papules and pustules has not been evaluated.
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Cleanse affected area(s) using only very mild soaps or soapless cleansing lotion and pat dry with a soft towel before application of azelaic acid gel. Apply and gently massage a thin layer of azelaic acid gel into the affected areas on the face twice daily (morning and evening). Wash hands immediately following application of azelaic acid gel. Cosmetics may be applied after the application of azelaic acid gel has dried. Reassess the diagnosis if no improvement is observed upon completing 12 weeks of therapy. Avoid the use of occlusive dressings or wrappings. Instruct patients to avoid use of alcoholic cleansers, tinctures and astringents, abrasives and peeling agents. For topical use. Not for oral, ophthalmic or intravaginal use. Apply a thin layer twice daily to affected area(s). ( 2 ) Use only very mild soaps or soapless cleansing lotion and pat dry with a soft towel before applying azelaic acid gel. ( 2 ) Wash hands immediately following application. ( 2 ) Cosmetics may be applied after the application of azelaic acid gel has dried. ( 2 ) Avoid use of alcoholic cleansers, tinctures and astringents, abrasives and peeling agents. ( 2 ) For topical use. ( 2 ) Not for oral, ophthalmic or intravaginal use. ( 2 )