Label: CLOTRIMAZOLE- clotrimazole solution
- NDC Code(s): 51672-2037-1
- Packager: Taro Pharmaceuticals U.S.A., Inc.
- 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 April 22, 2017
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- SPL UNCLASSIFIED SECTION
- Active ingredient
Clotrimazole USP, 1%Close
- cures most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis)
- effectively relieves
which can accompany these conditionsClose
For external use only
Stop use and ask a doctor if
- irritation occurs
- there is no improvement within 4 weeks (for athlete's foot and ringworm) or 2 weeks (for jock itch)
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
- This product is not effective on the scalp or nails For best results, follow directions and continue treatment for length of time indicated. For athlete's foot and ringworm: use daily for 4 weeks. For jock itch: use daily for 2 weeks.
- 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; change shoes and socks at least once dailyClose
- Other information
- Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
- Inactive ingredient
polyethylene glycol 400Close
- SPL UNCLASSIFIED SECTION
Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532
- PRINCIPAL DISPLAY PANEL - 10 mL Bottle Carton
Compare to the
Cures Most Athlete's Foot
Clotrimazole Topical Solution USP,1%
- Relieves Itching & Burning
(⅓ fl oz)
- INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51672-2037 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Clotrimazole (UNII: G07GZ97H65) (Clotrimazole - UNII:G07GZ97H65) Clotrimazole 1 g in 1 mL Inactive Ingredients Ingredient Name Strength polyethylene glycol 400 (UNII: B697894SGQ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51672-2037-1 1 in 1 CARTON 05/01/1996 1 10 mL in 1 BOTTLE; 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 05/01/1996 Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370) Establishment Name Address ID/FEI Business Operations Taro Pharmaceuticals Inc. 206263295 MANUFACTURE(51672-2037)