Label: MAJOR CLOTRIMAZOLE- clotrimazole cream
- NDC Code(s): 0904-7822-31, 0904-7822-36
- Packager: Major Pharmaceuticals
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated January 13, 2021
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- SPL UNCLASSIFIED SECTION
- Active ingredient
- Do not use on children under 2 years of age unless directed by a doctor.
- For external use only.
- Avoid contact with eyes.
- If irritation occurs or if there is no improvement within 4 weeks (for athlete's foot or ringworm) or within 2 weeks (for jock itch), discontinue use and consult a doctor.
- Clean the affected area and dry thoroughly.
- Apply a thin layer of this product 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 the spaces between the toes; wear well-fitting ventilated shoes, and change shoes and socks at least once daily.
- For athlete's foot and ringworm, use daily for 4 weeks. For jock itch, use daily for 2 weeks.
- If conditions persists longer, consult a doctor.
- This product is not effective on the scalp or nails.
- Other information
- Inactive ingredients
- Principal Display Panel – 1 oz. Tube
- Principal Display Panel – 1 oz. Carton
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0904-7822 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 WATER (UNII: 059QF0KO0R) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) POLYSORBATE 60 (UNII: CAL22UVI4M) BENZYL ALCOHOL (UNII: LKG8494WBH) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ALOE VERA LEAF (UNII: ZY81Z83H0X) OCTYLDODECANOL (UNII: 461N1O614Y) CETYL PALMITATE (UNII: 5ZA2S6B08X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0904-7822-31 1 in 1 CARTON 10/04/2004 1 28.35 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:0904-7822-36 1 in 1 CARTON 10/04/2004 2 14.17 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 10/04/2004 Labeler - Major Pharmaceuticals (191427277)