Label: CLOTRIMAZOLE CREAM, 1%- clotrimazole cream
- NDC Code(s): 45861-099-07
- Packager: Pharmaceutica North America, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 18, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
-
Warnings
- For external use only.
- Do not useon children under 2 years of age unless directed by a doctor.
- When using this product, avoid contact with eyes.
- Stop use and ask doctor if: irritation occurs, there is no improvement within 4 weeks (for athletes foot or ringworm) or within 2 weeks (for jock itch)
- Keep this and all drugs out of reach of children. In case of a accidental ingestion, seek professional assistance or contact a Poison Control Center right away.
- KEEP OUT OF REACH OF CHILDREN
-
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 athletes' 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 athletes 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
- Product label
-
INGREDIENTS AND APPEARANCE
CLOTRIMAZOLE CREAM, 1%
clotrimazole creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:45861-099 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:45861-099-07 29 g in 1 TUBE; Type 0: Not a Combination Product 12/10/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M005 12/10/2024 Labeler - Pharmaceutica North America, Inc (962739699)