Label: BIO-SCRIPTIVES EXTREME AF- tolnaftate cream

  • 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 27, 2011

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  • Active Ingredients

    Tolnaftate 1%

  • Purpose

    Antifungal

  • Uses

    ■  Proven clinically effective in the treatment of athlete's foot.
    ■  Relieves itching and burning feet.
  • Warnings

    ■  Do not use on children under 2 years of age.
    ■  Do not use for diaper rash.
    ■  For external use only.
    ■  Avoid contact with eyes.
  • Stop use and ask a doctor if

    • irritation occurs or if there is no improvement within 4 weeks.
  • Directions

    ■  Wash the feet and dry thoroughly.
    ■  Apply a thin layer of product to the feet once or twice daily (morning and/or night).
    ■  Supervise children in the use of this product.
    ■  Pay special attention to the spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily.
    ■  Do not use if safety seal is broken.


  • Inactive Ingredients

    Purified Water, Glyceryl Stearate SE, Stearyl Alcohol, Isopropyl Alcohol, Aloe Barbadensis Leaf Juice, Olive Oil, Menthol, Propylene Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, L-Arginine hydroxide, PEG-40 Hdrogenated Castor Oil, Eucalyptus Globulus, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Althaea Officinalis Extract, Echinacea Angustifolia Extract, Allantoin, Tagetes Erecta Extract, Sodium Chloride, Ascophyllum Nodosum Extract, Xanthan Gum, Azadirachta Indica (Neem) Seed Oil, Methylisothiazolinone

  • Reference

    Distributed by BioChemics dba Bio-Scriptives

    99 Rosewood Dr. #260 - Danvers, MA 01923

    978-750-0790


  • Labeling


    ExtremeAR Front Label

    ExtremeAR Back Label

  • Keep out of reach of children

    Enter section text here

  • INGREDIENTS AND APPEARANCE
    BIO-SCRIPTIVES EXTREME AF 
    tolnaftate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60608-013
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE.56 g  in 56.69 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    WATER (UNII: 059QF0KO0R)  
    ARGININE HYDROCHLORIDE (UNII: F7LTH1E20Y)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ALTHAEA OFFICINALIS ROOT (UNII: TRW2FUF47H)  
    ECHINACEA ANGUSTIFOLIA LEAF (UNII: FS7G8S6PJ8)  
    ASCOPHYLLUM NODOSUM (UNII: 168S4EO8YJ)  
    TAGETES ERECTA FLOWER (UNII: UH5X33P33E)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    MENTHOL (UNII: L7T10EIP3A)  
    EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    AZADIRACHTA INDICA SEED OIL (UNII: 4DKJ9B3K2T)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60608-013-0056.69 g in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C07/27/2011
    Labeler - BioChemics, Inc. (802946426)
    Establishment
    NameAddressID/FEIBusiness Operations
    Coastal Products Company782445688manufacture
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