Label: TM-CLOTRIMAZOLE- clotrimazole 1% cream
- NDC Code(s): 83035-1062-3
- Packager: Singular Dreamer, Ltd dba True Marker
- 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.
Drug Label Information
Updated April 10, 2023
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- 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
-
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 final part333C 04/03/2023 Labeler - Singular Dreamer, Ltd dba True Marker (129504103) Registrant - Singular Dreamer, Ltd dba True Marker (129504103)