Label: UPANDUP CLOTRIMAZOLE- clotrimazole cream
- NDC Code(s): 11673-910-12, 11673-910-16
- Packager: Target Corporation
- 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 (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis)
- for effective relief of
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.
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 dailyClose
- 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
Dist. by Target Corp.Close
Minneapolis, MN 55403
- PRINCIPAL DISPLAY PANEL - 30 g Tube Carton
clotrimazole cream USP, 1%
Compare to active ingredient in Lotrimin® AF*
helps cure most athlete's foot
helps relieve burning and itching
greaseless and non-staining
NET WT 1 OZ (30 g)
- INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11673-910 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:11673-910-12 1 in 1 CARTON 1 30 g in 1 TUBE 2 NDC:11673-910-16 1 in 1 CARTON 2 40 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 - Target Corporation (006961700) Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370) Establishment Name Address ID/FEI Business Operations Taro Pharmaceuticals Inc. 206263295 MANUFACTURE(11673-910)