DERMATIN ANTIFUNGAL (CLOTRIMAZOLE) CREAM [MELALEUCA, INC.]

DERMATIN ANTIFUNGAL (CLOTRIMAZOLE) CREAM [MELALEUCA, INC.]
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NDC 54473-206-01
Set ID 5ce14151-31cc-4e3f-ac32-008fe8bc2f3e
Category HUMAN OTC DRUG LABEL
Packager Melaleuca, Inc.
Generic Name
Product Class Azole Antifungal
Product Number
Application Number PART333C
  • ACTIVE INGREDIENT

    Active ingredient
    Clotrimazole 1%

  • PURPOSE

    Purpose
    Antifungal

  • INDICATIONS & USAGE

    Uses

    • Cures most athlete's foot, jock itch, and ringworm
    • Relieves itching, burning, cracking, scaling, and discomfort accompanying these conditions
  • WARNINGS

    Warnings
    For external use only

    • When using this product avoid contact with the eyes
  • DO NOT USE

    Do not use on children under 2 years of age unless directed by a doctor

  • STOP USE

    Stop use and ask a doctor if

    • irritation occurs
    • there is no improvement within 4 weeks (for athlete's foot and ringworm) or 2 weeks (for jock itch)
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • 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
  • 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

    image of label
  • INGREDIENTS AND APPEARANCE
    DERMATIN  ANTIFUNGAL
    clotrimazole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54473-206
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE0.01 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54473-206-0114 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C12/19/2011
    Labeler - Melaleuca, Inc. (139760102)
    Establishment
    NameAddressID/FEIBusiness Operations
    Melaleuca, Inc.139760102manufacture

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