Label: CVS PHARMACY ITCH RELIEF ANTIFUNGAL- clotrimazole cream
- NDC Code(s): 59779-510-01
- Packager: CVS Pharmacy
- 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 January 4, 2013
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- SPL UNCLASSIFIED SECTION
- Active ingredient
- cures most jock itch (tinea cruris)
- for effective relief of
For external use only
Stop use and ask a doctor if
- irritation occurs
- there is no improvement within 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 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
- Other information
- To open: unscrew cap, use the pointed end of cap to puncture seal.
- store between 2° - 30°C (36° - 86°F)
- see carton or tube crimp for lot number and expiration date
- Inactive ingredients
benzyl alcohol (1%), cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sorbitan monostearateClose
- SPL UNCLASSIFIED SECTION
Distributed by: CVS Pharmacy, Inc.Close
One CVS Drive, Woonsocket, RI 02895
- PRINCIPAL DISPLAY PANEL - 15 g Tube Carton
Compare to the active
ingredient in Lotrimin® AF*
CLOTRIMAZOLE CREAM USP, 1%
NET WT 0.5 OZ (15 g)
- INGREDIENTS AND APPEARANCE
CVS PHARMACY ITCH RELIEF ANTIFUNGAL
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-510 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 benzyl alcohol (UNII: LKG8494WBH) cetostearyl alcohol (UNII: 2DMT128M1S) cetyl esters wax (UNII: D072FFP9GU) octyldodecanol (UNII: 461N1O614Y) polysorbate 60 (UNII: CAL22UVI4M) water (UNII: 059QF0KO0R) sorbitan monostearate (UNII: NVZ4I0H58X) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59779-510-01 1 in 1 CARTON 1 15 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part333C 08/31/1993 Labeler - CVS Pharmacy (062312574) Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370) Establishment Name Address ID/FEI Business Operations Taro Pharmaceuticals Inc. 206263295 MANUFACTURE(59779-510)