Label: CLOTRIMAZOLE cream
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Contains inactivated NDC Code(s)
NDC Code(s): 54162-018-05 - Packager: Geritrex Corp
- 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.
Drug Label Information
Updated July 29, 2014
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- Drug Facts
- Uses
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Directions
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 products.This products does not work on the scalp or nail. For athlet's foot and ringworm pay special attention to spaces between the toes: wear well fitting, ventilates shoes, and change shoes and socks at least once every day. Use every day for 4 weeks. For jock itch, use every day for 2 weeks. If condition lasts longer, contact a doctor.
- Warnings
- Inactive Ingredients
- KEEP OUT OF REACH OF CHILDREN
- STORAGE AND HANDLING
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CLOTRIMAZOLE
clotrimazole creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54162-018 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE 1 g in 100 g Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL (UNII: LKG8494WBH) CETEARETH-2 PHOSPHATE (UNII: 8NSU66JGZR) CETYL ALCOHOL (UNII: 936JST6JCN) CITRIC ACID ACETATE (UNII: DSO12WL7AU) PARAFFIN (UNII: I9O0E3H2ZE) PETROLATUM (UNII: 4T6H12BN9U) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SODIUM CITRATE (UNII: 1Q73Q2JULR) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54162-018-05 14 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 07/29/2014 Labeler - Geritrex Corp (112796248) Registrant - Geritrex Corp (112796248) Establishment Name Address ID/FEI Business Operations Geritrex Corp 112796248 manufacture(54162-018)