Label: ANTI-FUNGAL- clotrimazole cream
- 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.
Updated March 14, 2013
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- Active Ingredient
For exteranl use only.
If swallowed, get medical help or contact a Poison Control Center right away.
Do not use on children under 2 years of age unless directed by a doctor.
Avoid contact with the eyes.
If irritation occurs or if there is no improvement within 2 weeks, discontinue use and consult a doctor.
Clean 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 persists longer, consult a doctor. This product is not effective on the scalp or nails.
- Inactive Ingredients
- Package Label
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66977-023 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 CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L) TRICAPRIN (UNII: O1PB8EU98M) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) EDETATE DISODIUM (UNII: 7FLD91C86K) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TROLAMINE (UNII: 9O3K93S3TK) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66977-023-04 113 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 10/14/2002 Labeler - MPM Medical, Inc. (119643406) Establishment Name Address ID/FEI Business Operations Biomed Laboratories, LLC 055329696 manufacture(66977-023)