Drug Catalog - Product Detail
CICLOPIROX SHAMPOO 1% LIQ 120ML
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00591-2159-90 | ACTAVIS PHARMA | 120 | 1% | SHAMPOO |
PACKAGE FILES
Generic Name
CICLOPIROX
Substance Name
CICLOPIROX
Product Type
HUMAN PRESCRIPTION DRUG
Route
TOPICAL
Application Number
ANDA090490
Description
11 DESCRIPTION Ciclopirox Shampoo 1% contains the synthetic antifungal agent, ciclopirox for topical use. Each gram (equivalent to 0.96 mL) of Ciclopirox Shampoo 1% contains 10 mg ciclopirox, USP in a shampoo base consisting of purified water USP, sodium laureth sulfate, disodium laureth sulfosuccinate, sodium chloride USP, and laureth-2. Ciclopirox Shampoo 1% is a colorless, translucent solution. The chemical name for ciclopirox is 6-cyclohexyl-1-hydroxy-4-methyl-2(1 H )-pyridone, with the molecular formula C 12 H 17 NO 2 and a molecular weight of 207.27. The CAS Registry Number is [29342-05-0]. The chemical structure is: ac2cca62-figure-01
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Ciclopirox Shampoo 1% is colorless and translucent, and supplied in 120 mL plastic bottles (NDC 0591-2159-90). Discard unused product after initial treatment duration. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Keep out of reach of children.
Indications & Usage
1 INDICATIONS AND USAGE Ciclopirox Shampoo 1% is indicated for the topical treatment of seborrheic dermatitis of the scalp in adults. Ciclopirox Shampoo 1% is an antifungal indicated for the topical treatment of seborrheic dermatitis of the scalp in adults. ( 1 )
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Ciclopirox Shampoo 1% is not for ophthalmic, oral, or intravaginal use. Wet hair and apply approximately 1 teaspoon (5 mL) of Ciclopirox Shampoo 1% to the scalp. Up to 2 teaspoons (10 mL) may be used for long hair. Lather and leave on hair and scalp for 3 minutes. A timer may be used. Avoid contact with eyes. Rinse off. Treatment should be repeated twice per week for 4 weeks, with a minimum of 3 days between applications. If a patient with seborrheic dermatitis shows no clinical improvement after 4 weeks of treatment with Ciclopirox Shampoo 1%, the diagnosis should be reviewed. Apply approximately 1 teaspoon of Ciclopirox Shampoo 1% to the scalp twice per week for 4 weeks. ( 2 ) For topical use only. Not for ophthalmic, oral, or intravaginal use. ( 2 )