NDC | 42479-212-17 |
Set ID | d1e56f5f-3665-420c-9753-6c1c38ba112f |
Category | HUMAN OTC DRUG LABEL |
Packager | KVG Group Inc |
Generic Name | |
Product Class | Azole Antifungal |
Product Number | |
Application Number | PART333 |
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- SPL UNCLASSIFIED SECTION
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
Directions
- Clean the affected area and dry thoroughly
- Hold can upright
- Shake can well before each use
- Spray a thin layer of the product over the affected area twice daily (morning and night) or as directed by a doctor.
- Supervise children in the use of this product
-
For athlete’s foot and ringworm, use
daily for 4 weeks
- If condition persists longer, consult a doctor
- SPL UNCLASSIFIED SECTION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
FOOTLOGIX
clotrimazole aerosol, sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42479-212 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE 1 mL in 100 mL Inactive Ingredients Ingredient Name Strength BUTANE (UNII: 6LV4FOR43R) PANTHENOL (UNII: WV9CM0O67Z) PROPANE (UNII: T75W9911L6) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) AVOCADO (UNII: SDS87L369F) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42479-212-17 50 mL in 1 CAN Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333 09/01/2010 Labeler - KVG Group Inc (206932605) Establishment Name Address ID/FEI Business Operations Assured Packaging Inc 248916165 manufacture