Label: DERMATIN ANTIFUNGAL- clotrimazole cream
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Contains inactivated NDC Code(s)
NDC Code(s): 54473-206-01 - Packager: Melaleuca, Inc.
- 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 February 17, 2011
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions
- clean the affected area and dry thoroughly
- apply a thin layer of the product over the affected area twice daily (morning and night) or as directed by a physician
- children under 12 years of age should be supervised 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
- for athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks
- this product is not effective on scalp or nails
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INACTIVE INGREDIENT
Other ingredients acrylates/C10-30 alkyl acrylates crosspolymer, benzyl alcohol, cetyl alcohol, deionized water, dimethicone, glyceryl stearate and PEG-100 stearate, propylene glycol, SD alcohol 40B, steareth-2, steareth-21, stearic acid, T36-C5® Melaleuca alternifolia (Tea Tree) leaf oil, triethanolamine.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DERMATIN ANTIFUNGAL
clotrimazole creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54473-206 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE 0.01 g in 1 g Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) BENZYL ALCOHOL (UNII: LKG8494WBH) CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 1G56KV7BUJ) CETYL ALCOHOL (UNII: 936JST6JCN) DIMETHICONE (UNII: 92RU3N3Y1O) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) POLYOXYL 100 STEARATE (UNII: YD01N1999R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) STEARETH-2 (UNII: V56DFE46J5) STEARETH-21 (UNII: 53J3F32P58) STEARIC ACID (UNII: 4ELV7Z65AP) TEA TREE OIL (UNII: VIF565UC2G) TROLAMINE (UNII: 9O3K93S3TK) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54473-206-01 14 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 12/19/2011 Labeler - Melaleuca, Inc. (139760102) Establishment Name Address ID/FEI Business Operations Melaleuca, Inc. 139760102 manufacture