Label: TM-CLOTRIMAZOLE- clotrimazole 1% cream
- NDC Code(s): 83035-1062-3
- Packager: Singular Dreamer, Ltd dba True Marker
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated October 7, 2024
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- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Uses
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Warnings
- For external use only
- Do Not Use – On children under 2 years of age unless directed by a doctor.
- When using this product, avoid contact with eyes.
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Stop use and ask a doctor if
● Irritation occurs
● There is no improvement within 4 weeks (for athlete's foot or ringworm) or within 2 weeks (for jock itch). - Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center right away.
- KEEP OUT OF REACH OF CHILDREN
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Directions
- Wash the 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 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 condition persists longer, consult a doctor.
- This product is not effective on the scalp or nails.
- Other information
- Inactive ingredients
- Questions?
- Product label
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INGREDIENTS AND APPEARANCE
TM-CLOTRIMAZOLE
clotrimazole 1% creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83035-1062 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 BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ALCOHOL (UNII: 3K9958V90M) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) DIMETHYL SULFOXIDE (UNII: YOW8V9698H) EDETATE DISODIUM (UNII: 7FLD91C86K) ETHYLPARABEN (UNII: 14255EXE39) GLYCERIN (UNII: PDC6A3C0OX) MINERAL OIL (UNII: T5L8T28FGP) GLYCERYL MONO AND DIPALMITOSTEARATE (UNII: KC98RO82HJ) PETROLATUM (UNII: 4T6H12BN9U) GLYCERETH-31 (UNII: 11L9WC241B) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83035-1062-3 1 in 1 CARTON 04/03/2023 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 04/03/2023 Labeler - Singular Dreamer, Ltd dba True Marker (129504103) Registrant - Singular Dreamer, Ltd dba True Marker (129504103)