NDC | 55312-305-01 |
Set ID | 973dfacf-9398-4880-a12a-7c83e4f1c820 |
Category | HUMAN OTC DRUG LABEL |
Packager | Western Family Foods Inc |
Generic Name | |
Product Class | Azole Antifungal |
Product Number | |
Application Number | PART333C |
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
- cures most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis)
- for effective relief of
- itching
- scaling
- cracking
- burning
- redness
- soreness
- irritation
- discomfort
- Warnings
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 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.
- Directions
This product is not effective on the scalp or nails.
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 daily
Close - 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 monostearate
Close - Questions?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 15 g Tube Carton
Athlete's
Foot CreamClotrimazole Cream USP, 1%
ANTIFUNGAL CREAMRelieves
Itching, Burning,
Scaling and CrackingNET WT 1/2 OZ (15 g)
- INGREDIENTS AND APPEARANCE
WESTERN FAMILY ATHLETES FOOT
clotrimazole creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55312-305 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55312-305-01 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 - Western Family Foods Inc (192166072) Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370) Establishment Name Address ID/FEI Business Operations Taro Pharmaceuticals Inc. 206263295 MANUFACTURE(55312-305)