Label: AFTATE ATHLETE FOOT CREAM- tolnaftate cream

  • NDC Code(s): 70356-001-01, 70356-001-05
  • Packager: Sabel Med LLC
  • 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 November 23, 2016

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  • ACTIVE INGREDIENT

    Active Ingredient-USA

  • DOSAGE & ADMINISTRATION

    tolnaftate dosage directions USA

  • INACTIVE INGREDIENT

    tolnaftate inactive USA

  • WARNINGS

    tolnaftate warnings USA

  • KEEP OUT OF REACH OF CHILDREN

    Tolnaftate keep out of reach

  • PURPOSE

    tolnaftate purpose USA

  • INDICATIONS & USAGE

    tolnaftate usage USA

  • PRINCIPAL DISPLAY PANEL

    tolnaftate pdp USA

  • INGREDIENTS AND APPEARANCE
    AFTATE ATHLETE FOOT CREAM 
    tolnaftate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70356-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PROPYLENE GLYCOL 1-(2-METHYLBUTYRATE) (UNII: 9Q5W5G6461)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    CHLOROCRESOL (UNII: 36W53O7109)  
    CETETH-20 (UNII: I835H2IHHX)  
    WATER (UNII: 059QF0KO0R)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70356-001-0128 g in 1 TUBE; Type 0: Not a Combination Product12/02/2016
    2NDC:70356-001-0514 g in 1 TUBE; Type 0: Not a Combination Product12/02/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C12/01/2016
    Labeler - Sabel Med LLC (091476000)
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