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DermaTAF Antifungal Treatment by DermaTAF, Inc.

Dosage form: solution
Ingredients: TOLNAFTATE 1mL in 100mL
Labeler: DermaTAF, Inc.
NDC Code: 50080-001

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.

DermaTAF Antifungal Treatment Tolnaftate 1% Antifungal Solution

DermaTAF Antifungal Treatment Tolnaftate 1% Antifungal Solution


Active Ingredient:

Tolnaftate 1%

Purpose

Antifungal

Uses:
  • For effective treatment of most athlete's foot and ringworm
  • Relieves
    • itching
    • scaling
    • cracking
    • burning
    • redness
    • soreness
    • irritation
  • Prevents the recurrence of most athlete's foot (dermatophytosis) with daily use.

Warnings

For external use only.

Do not use on children under 2 years of age.

Avoid contact with the eyes.

When using this product for athlete's foot or ringworm:

If irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a doctor.

When using this product for the prevention of athlete's foot:

If irritation occurs, discontinue use and consult a doctor.

Do not use for diaper rash.

Keep out of reach of children.

Directions:
  • Clean the affected area and dry thoroughly.
  • Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor.
  • For athlete's foot: Pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.
  • For athlete's foot and ringworm, use daily for 4 weeks.
  • If condition persists longer, consult a doctor.
  • This product is not effective on the scalp or nails.
  • To prevent athlete's foot, clean the feet and dry thoroughly.
  • Apply a thin layer of the product to the feet once or twice daily (morning and night).
  • Pay special attention to spaces between the toes, wear well-fitting, ventilated shoes and change shoes and socks at least once daily.
  • Supervise children in the use of this product.

Inactive Ingredients:

Allantoin, Caprylic Triglycerides, Cetrimonium Chloride, Cocomidopropyl betaine, Cocomidopropylamine Oxide, Dicaprlylate Dicaprate, Didecyldimonium Chloride, Epigallocatechin gallate, Isopropryl palmitate, Phemerol Chloride, Polyquaternium 37, PP G-1 Trideceth-6, Propylene Glycol, Quaternium-15, Water

Manufactured for: DermaTAF, Inc.

Lake Forest, CA 92630

Made in U.S.A

www.dermataf.com


Questions or Comments?

1-866-406-7926

Monday thru Friday

8:00am to 5:00pm Western Time

BATCH: XXXXXX

EXP.DATE: XXXXXX

DermaTAF Antifungal Treatment Tolnaftate 1% Antifungal Solution 0.5oz/15ml (50080-001-15)

DERMATAF ANTIFUNGAL TREATMENT 
tolnaftate solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50080-001
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (TOLNAFTATE) TOLNAFTATE1 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALLANTOIN 
TRICAPRYLIN 
CETRIMONIUM CHLORIDE 
COCAMIDOPROPYL BETAINE 
COCAMIDOPROPYLAMINE OXIDE 
DIDECYLDIMETHYLAMMONIUM CHLORIDE 
EPIGALLOCATECHIN GALLATE 
ISOPROPYL PALMITATE 
BENZETHONIUM CHLORIDE 
PPG-1 TRIDECETH-6 
PROPYLENE GLYCOL 
QUATERNIUM-15 
WATER 
Packaging
#Item CodePackage Description
1NDC:50080-001-151 BOTTLE (BOTTLE) in 1 BOX
115 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C05/24/2012
Labeler - DermaTAF, Inc. (044676602)
Registrant - DermaTAF, Inc. (044676602)
Establishment
NameAddressID/FEIOperations
Health Specialty.com794053863manufacture

Revised: 05/2012
 
DermaTAF, Inc.

← See all DermaTAF Antifungal Treatment brands

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 combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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