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Kiss Fungi-Gone Anti-fungal Treatment

Dosage form: liquid
Ingredients: TOLNAFTATE 10mg in 1mL
Labeler: Kiss Products, Inc.
NDC Code: 42432-019

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.

Kiss Fungi-Gone Antifungal Treatment - Drug Facts

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.jpg FungiGoneHalfOunceCarton.jpg FungiGoneOneOunceLabel.jpg FungiGoneOneOunceCarton1.jpg FungiGoneOneOunceCarton2.jpg

KISS FUNGI-GONE  ANTI-FUNGAL TREATMENT
tolnaftate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42432-019
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (TOLNAFTATE) TOLNAFTATE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ACETONE 
PROPYLENE GLYCOL 
WATER 
POLYSORBATE 80 
UNDECYLENIC ACID 
ALOE VERA LEAF 
ALPHA-TOCOPHEROL ACETATE 
Packaging
#Item CodePackage Description
1NDC:42432-019-041 BOTTLE, WITH APPLICATOR in 1 BOX
1NDC:42432-019-0315 mL in 1 BOTTLE, WITH APPLICATOR
2NDC:42432-019-061 BOTTLE, WITH APPLICATOR in 1 BOX
2NDC:42432-019-0530 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)
Establishment
NameAddressID/FEIOperations
Dhaliwal Labs016754201manufacture(42432-019)

Revised: 10/2012
Document Id: d4b79b4b-b867-4e55-a3d8-bd158a3220b4
Set id: 09a9d224-6606-4efe-9e73-c74ef2bc99cf
Version: 7
Effective Time: 20121023
 
Kiss Products, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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