NDC | 55319-334-14 |
Set ID | 590b3e00-7512-480a-9501-f79e66de5b19 |
Category | HUMAN OTC DRUG LABEL |
Packager | Family Dollar |
Generic Name | |
Product Class | Azole Antifungal |
Product Number | |
Application Number | PART333C |
- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
- DO NOT USE
- WHEN USING
- STOP USE
- PREGNANCY OR BREAST FEEDING
- 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 toes, wear well-fitting, ventilated shoes and change shoes and socks at least once a day
- For athlete's foot and ringworm use daily for 4 weeks, for jock itch use daily for 2 weeks
- If condition persists longer, ask a doctor
- This product is no effective on the scalp or nails
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- QUESTIONS
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
FAMILY WELLNESS ANTIFUNGAL
clotrimazole creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55319-334 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 CETYL ALCOHOL (UNII: 936JST6JCN) MINERAL OIL (UNII: T5L8T28FGP) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) OCTYLDODECANOL (UNII: 461N1O614Y) BENZYL ALCOHOL (UNII: LKG8494WBH) POLYSORBATE 60 (UNII: CAL22UVI4M) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) STEARIC ACID (UNII: 4ELV7Z65AP) SODIUM HYDROXIDE (UNII: 55X04QC32I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55319-334-14 1 in 1 BOX 11/08/2016 1 14 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 01/20/2014 Labeler - Family Dollar (024472631)