Label: CLOTRIMAZOLE 1% ATHLETES FOOT- clotrimazole cream
- NDC Code(s): 59779-305-01, 59779-305-02
- Packager: CVS Pharmacy
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- SPL UNCLASSIFIED SECTION
- Active ingredient
- cures most athlete's foot, jock itch and ringworm
- relieves itching, burning, cracking, scaling and discomfort which accompany these conditions
For external use only
Stop use and ask a doctor if
- irritation occurs
- there is no improvement within 4 weeks (for athlete's foot or 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.
- wash affected area and dry thoroughly
- apply a thin layer over affected area twice daily (morning and night)
- 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 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, ask a doctor
- this product is not effective on the scalp or nails
- Other information
- To open: unscrew cap, use the pointed end of cap to puncture seal.
- store between 20° - 25°C (68° - 77°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
CVS Pharmacy, Inc.
One CVS Drive
Woonsocket, RI 02895
- PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton
Compare to the active
ingredient in Lotrimin® AF*
CLOTRIMAZOLE CREAM USP, 1%
CURES MOST ATHLETE'S FOOT
NET WT 1 OZ (28.4 g)
- INGREDIENTS AND APPEARANCE
CLOTRIMAZOLE 1% ATHLETES FOOT
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-305 Route of Administration TOPICAL DEA Schedule 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59779-305-01 1 in 1 CARTON 1 15 g in 1 TUBE 2 NDC:59779-305-02 1 in 1 CARTON 2 30 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(59779-305)