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TOLNAFTATE ANTIFUNGAL by Major Pharmaceuticals

Medically reviewed on November 13, 2017

Dosage form: powder
Ingredients: TOLNAFTATE 1g in 100g
Labeler: Major Pharmaceuticals
NDC Code: 0904-0726

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.

major tolnaftate

Active Ingredient

Tolnaftate 1 %

Purpose Section

Antifungal

Uses
  • for effective treatment of most athlete's foot (linea pedis), jock itch (tinea cruris) and ring worm (tiea corporis)
  • for effective relief of itchy, scaly skin between the toes
  • clears up most athlete's foot infection and with daily use helps to keep it from coming back

Warnings

Do not use on children under 2 years of age.

Do not use for diaper rash.

For external use only

When using this product avoid contact with the eyes

Stop use and consult a doctor if

  • irritation occurs or if there is no improvement within 4 weeks (for athlete's foot and ringworm)
  • irritation occurs or if there is no improvement within 2 weeks (for jock itch)

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions
  • shake well before use
  • 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
  • supervise children in the use of this product

For athlete's foot

  • use daily for 4 weeks. If condition persists longer, consult a doctor
  • pay special attention to the spaces between the toes
  • wear well-fitting ventilated shoes
  • change shoes and socks at least once a daily
  • to prevent athlete's foot, clean and dry feet thoroughly.

Apply as above or twice daily

For ringworm

  • use only for 4 weeks. If condition persists longer, consult a doctor.

For jock itch

  • use daily for 2 weeks. If condition persists longer, consuly a doctor.

This product is not effective on the scalp or nails.

Other Information
  • store at room temperature

Inactive Ingredients

starch and talc

Questions or comments?

Call: 800-616-2471

Package Label

NDC 0904-0726-45

TOLNAFTATE ANTIFUNGAL POWDER 1%

Cures Athlete's Foot Jock Itch Fungi and Ringworm

Compare to the active ingredient on Tinactin*

MAJOR

net Wt. 45g (1 1/2 oz.)

TOLNAFTATE ANTIFUNGAL 
tolnaftate powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-0726(NDC:75841-199)
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (TOLNAFTATE) TOLNAFTATE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
TALC 
Packaging
#Item CodePackage Description
1NDC:0904-0726-4545 g in 1 BOTTLE, DISPENSING
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C11/01/2011
Labeler - Major Pharmaceuticals (191427277)
Registrant - GCP Laboratories (965480861)
Establishment
NameAddressID/FEIOperations
GCP Laboratories965480861manufacture(0904-0726), relabel(0904-0726)

 
Major Pharmaceuticals

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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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