Label: KISS FUNGI-GONE ANTI-FUNGAL TREATMENT- tolnaftate liquid

  • 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 25, 2015

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  • Active Ingredient

    Tolnaftate 1%

  • Purpose

    Anti-fungal

  • Uses

    For the cure of:

    • athlete's foot (tinea pedis)
    • jock itch (tinea cruris)
    • ringworm (tinea corporis)

    For the relief of:

    • itching
    • cracking
    • burning
    • scaling
    • discomfort associated with the above condition
  • Warnings

    For external use only. Avoid contact with eyes.

  • Do not use

    • for bacterial infections
    • for diaper rash
    • on children under 2 years of age unless directed by a doctor
  • Do not use and ask doctor if:

    • irritation occurs
    • there is no improvement within 4 weeks
  • KEEP OUT OF REACH OF CHILDREN.

    In case of accidental ingestion, get medical help or contact Poison
    Control Center right away. As with any drug, if pregnant or nursing a baby, consult with a doctor before using.

  • Directions

    • Shake well before using
    • Clean area with soap and water, dry thoroughly
    • Apply thin layer over affected area 2 times a day
    • For athlete's foot, use daily for 4 weeks or as directed by a physician
    • Allow solution to soak into the skin before putting socks on
    • This product is not effective on nails and scalp
  • Other Information

    This product contains Acetone. Do not use near heat or flame.

  • Inactive Ingredients

    Acetone, Water, Propylene Glycol, Polysorbate 80, Undecylenic Acid, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate (Vitamin E)

  • Image of Labels and Cartons

    FungiGoneHalfOunceLabel.jpgHalfOunceLabel FungiGoneHalfOunceCarton.jpgHalfOunceCarton FungiGoneOneOunceLabel.jpgOunceLabel FungiGoneOneOunceCarton1.jpgOunceCarton1 FungiGoneOneOunceCarton2.jpgOunceCarton2

  • INGREDIENTS AND APPEARANCE
    KISS FUNGI-GONE  ANTI-FUNGAL TREATMENT
    tolnaftate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42432-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACETONE (UNII: 1364PS73AF)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    UNDECYLENIC ACID (UNII: K3D86KJ24N)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42432-101-041 in 1 BOX
    1NDC:42432-101-0315 mL in 1 BOTTLE, WITH APPLICATOR
    2NDC:42432-101-511 in 1 BOX
    2NDC:42432-101-1115 mL in 1 BOTTLE, WITH APPLICATOR
    3NDC:42432-101-061 in 1 BOX
    3NDC:42432-101-0530 mL in 1 BOTTLE, WITH APPLICATOR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C10/23/2012
    Labeler - Kiss Products, Inc. (626892020)
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