Label: CLOTRIMAZOLE- drs. clotrimazole cream
- NDC Code(s): 80489-002-01
- Packager: OL PHARMA TECH,LLC
- Category: HUMAN OTC DRUG LABEL
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 October 2, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- USES
- warnings
- Do not use:
- WHEN USING THIS PRODUCT
- Stop use and ask your doctor if:
- Keep out of reach of children.
-
Directions:
- wash the affected area and dry thoroughly
- apply a thin layer of the 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 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 lasts longer, contact a doctor
- this product is not effective on the scalp or nails
- Other information
- Inactive ingredients
- For Questions:
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
CLOTRIMAZOLE
drs. clotrimazole creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80489-002 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 CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) EDETATE DISODIUM (UNII: 7FLD91C86K) CETEARETH-12 (UNII: 7V4MR24V5P) METHYLPARABEN (UNII: A2I8C7HI9T) STEARIC ACID (UNII: 4ELV7Z65AP) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) MINERAL OIL (UNII: T5L8T28FGP) SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B) TROLAMINE (UNII: 9O3K93S3TK) WATER (UNII: 059QF0KO0R) PROPYLPARABEN (UNII: Z8IX2SC1OH) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80489-002-01 1 in 1 CARTON 01/01/2021 1 28.3 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 01/01/2021 Labeler - OL PHARMA TECH,LLC (021170377) Registrant - OL PHARMA TECH,LLC (021170377) Establishment Name Address ID/FEI Business Operations OL PHARMA TECH,LLC (Drs, pharmacy) 021170377 manufacture(80489-002)