NDC | 59428-359-28 |
Set ID | 7d5f66e9-12b2-4251-861d-3ed354f76c31 |
Category | HUMAN OTC DRUG LABEL |
Packager | Zapotol Corp. |
Generic Name | |
Product Class | Azole Antifungal |
Product Number | |
Application Number | PART333C |
- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
- WHEN USING
- ASK DOCTOR
- KEEP OUT OF REACH OF CHILDREN
-
INDICATIONS & USAGE
Direction
- Wash affected area and dry thoroughly
- Apply a thin layer over 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, 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 not effective on the scalp or nails
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ZAPOTOL CLOTRIMAZOLE
clotrimazol creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59428-359 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE 10 mg in 100 g Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL (UNII: LKG8494WBH) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) PARAFFIN (UNII: I9O0E3H2ZE) POLYSORBATE 60 (UNII: CAL22UVI4M) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) STEARIC ACID (UNII: 4ELV7Z65AP) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59428-359-28 1 in 1 CARTON 10/13/2016 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 08/07/2012 Labeler - Zapotol Corp. (186063850)