Label: SUNMARK CLOTRIMAZOLE- clotrimazole cream
- NDC Code(s): 49348-279-72
- Packager: Strategic Sourcing Services LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 12, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
- Warnings
-
Directions
- for best results, follow directions and continue treatment for length of time indicated
- to open, use pointed end on cap to puncture seal
- clean skin with soap and water and dry thoroughly
- apply a thin layer over affected area morning and evening
- 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 daily
- best results in athlete's foot and ringworm are usually obtained with 4 weeks use, and in jock itch, with 2 weeks use. If satisfactory results have not occurred within these times, ask a doctor or pharmacist.
- children under 12 years of age should be supervised in the use of this product
- this product is not effective on the scalp or nails
- Other information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 30 g Tube Carton
-
INGREDIENTS AND APPEARANCE
SUNMARK CLOTRIMAZOLE
clotrimazole creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49348-279 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) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETYL ESTERS WAX (UNII: D072FFP9GU) OCTYLDODECANOL (UNII: 461N1O614Y) POLYSORBATE 60 (UNII: CAL22UVI4M) WATER (UNII: 059QF0KO0R) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49348-279-72 1 in 1 CARTON 08/31/1993 1 30 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 Drug M005 08/31/1993 Labeler - Strategic Sourcing Services LLC (116956644) Establishment Name Address ID/FEI Business Operations Taro Pharmaceuticals Inc. 206263295 manufacture(49348-279)