Label: RUGBY CLOTRIMAZOLE ANTIFUNGAL CREAM- clotrimazole cream
- NDC Code(s): 0536-1265-11, 0536-1265-26, 0536-1265-95
- Packager: Rugby Laboratories
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated February 14, 2024
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- Active ingredient
- Purpose
- KEEP OUT OF REACH OF CHILDREN
- Uses
- Warnings
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Directions
- Wash 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.
- Stop Use and ask a doctor if
- Inactive Ingredients
- Other Information
- Other Information
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- Packaging and Label
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
RUGBY CLOTRIMAZOLE ANTIFUNGAL CREAM
clotrimazole creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-1265 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE 1 g in 100 g Inactive Ingredients Ingredient Name Strength DIMETHYL SULFOXIDE (UNII: YOW8V9698H) ETHYLPARABEN (UNII: 14255EXE39) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) LAURETH-23 (UNII: N72LMW566G) LIGHT MINERAL OIL (UNII: N6K5787QVP) PETROLATUM (UNII: 4T6H12BN9U) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) WATER (UNII: 059QF0KO0R) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0536-1265-26 1 in 1 BOX 03/19/2020 1 45 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:0536-1265-95 1 in 1 BOX 11/20/2023 2 28 g in 1 TUBE; Type 0: Not a Combination Product 3 NDC:0536-1265-11 1 in 1 BOX 11/20/2023 3 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 Drug M005 03/19/2020 Labeler - Rugby Laboratories (079246066) Registrant - Trifecta Pharmaceuticals USA LLC (079424163)