Label: MAJOR CLOTRIMAZOLE- clotrimazole cream
- NDC Code(s): 71205-438-05
- Packager: Proficient Rx LP
- This is a repackaged label.
- Source NDC Code(s): 0904-7822
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 1, 2024
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
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Warnings
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- Do not use on children under 2 years of age unless directed by a doctor.
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- For external use only.
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- Avoid contact with eyes.
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- 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.
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Directions
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- Clean the affected area and dry thoroughly.
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- Apply a thin layer of this product over affected area twice daily (morning and night), or as directed by a doctor.
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- Supervise children in the use of this product.
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- 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.
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- For athlete's foot and ringworm, use daily for 4 weeks. For jock itch, use daily for 2 weeks.
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- If conditions persists longer, consult a doctor.
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- This product is not effective on the scalp or nails.
- Other information
- Inactive ingredients
- Questions?
- Principal Display Panel – ½ oz. Tube
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INGREDIENTS AND APPEARANCE
MAJOR CLOTRIMAZOLE
clotrimazole creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71205-438(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:71205-438-05 1 in 1 CARTON 07/02/2020 1 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 10/04/2004 Labeler - Proficient Rx LP (079196022) Establishment Name Address ID/FEI Business Operations Proficient Rx LP 079196022 REPACK(71205-438) , RELABEL(71205-438)
