NDC | 63868-595-28 |
Set ID | c3f36ba3-476f-4727-ac31-fe28251aecd1 |
Category | HUMAN OTC DRUG LABEL |
Packager | Chain Drug Marketing Association |
Generic Name | |
Product Class | Azole Antifungal |
Product Number | |
Application Number | PART333C |
- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
-
INDICATIONS & USAGE
Directions
- wash affected area and dry thoroughly
- apply a thin layer over affected area twice daily (morning and night)
- supervise children in the use of this product
- for athlete's foot: pay special attention to spaces between the toesl; wear well-fitting, ventilated shoes and change shoes and socks at least once daily
- if condition persists longer, ask a doctor
- this product is not effective on the scalp or nails
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
QUALITY CHOICE CLOTRIMAZOLE
clotrimazole creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-595 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE 10 mg in 1 g Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL (UNII: LKG8494WBH) PARAFFIN (UNII: I9O0E3H2ZE) OCTYLDODECANOL (UNII: 461N1O614Y) POLYSORBATE 60 (UNII: CAL22UVI4M) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM HYDROXIDE (UNII: 55X04QC32I) STEARIC ACID (UNII: 4ELV7Z65AP) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63868-595-28 1 in 1 CARTON 01/20/2015 1 28 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 01/19/2015 Labeler - Chain Drug Marketing Association (011920774)