NDC | 51852-103-01 |
Set ID | bca482ac-4b65-450e-bc27-c50af9cd0416 |
Category | HUMAN OTC DRUG LABEL |
Packager | LIFElabs, a Division of Atico International USA, INC. |
Generic Name | |
Product Class | Azole Antifungal |
Product Number | |
Application Number | PART333C |
- Clotrimazole
- PURPOSE
- WARNINGS
- INDICATIONS & USAGE
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
Directions
- 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 conditions persist longer, ask a doctor
- this product is not effective on the scalp or nails
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
CLOTRIMAZOLE
clotrimazole creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51852-103 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) Isopropyl Myristate (UNII: 0RE8K4LNJS) Mineral Oil (UNII: T5L8T28FGP) Polysorbate 60 (UNII: CAL22UVI4M) Propylene Glycol (UNII: 6DC9Q167V3) Water (UNII: 059QF0KO0R) Stearic Acid (UNII: 4ELV7Z65AP) Stearyl Alcohol (UNII: 2KR89I4H1Y) Sorbitan Monostearate (UNII: NVZ4I0H58X) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51852-103-01 1 in 1 BOX 1 28 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 11/01/2010 Labeler - LIFElabs, a Division of Atico International USA, INC. (073876450)