KISS FUNGI-GONE ANTI-FUNGAL TREATMENT (TOLNAFTATE) LIQUID [KISS PRODUCTS, INC.]

KISS FUNGI-GONE ANTI-FUNGAL TREATMENT (TOLNAFTATE) LIQUID [KISS PRODUCTS, INC.]
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NDC 42432-101-03, 42432-101-04, 42432-101-05, 42432-101-06, 42432-101-11, 42432-101-51
Set ID 09a9d224-6606-4efe-9e73-c74ef2bc99cf
Category HUMAN OTC DRUG LABEL
Packager Kiss Products, Inc.
Generic Name
Product Class
Product Number
Application Number PART333C
  • 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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