FORMULA 3- tolnaftate solution 
The Tetra Corporation

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.

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Active ingredient

Tolnaftate 1 percent

Purpose

Antifungal

Uses

For effective treatment of most athlete's foot and ringworm.

Relieves:

  • Itching
  • Soreness
  • Scaling
  • Burning
  • Cracking
  • Irritation
  • Redness

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 unless directed by a doctor.

When using this product avoid contact with eyes.

Stop use and ask a doctor if

  • When using 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 for the prevention of athlete's foot: If irritation occurs,discontinue use and consult a doctor.

If pregnant or breastfeeding ask a health professional before use.



Keep out of reach of children.

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

Directions

For treatment of athlete's foot and ringworm

  • 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: 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 scalp or nail.

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/or night)
  • Supervise children in the use of this product.
  • Pay special attention to spaces between the toes; wear well fitting, ventilated shoes, and change shoes and socks at least once daily.

Inactive ingredients

Apricot Kernel Oil, Rice Bran Oil, Sesame Seed Oil, Safflower Oil, Jojoba Oil, Vitamin E Acetate, Tennox, Methyl Paraben, Propyl Paraben and Butyl Paraben.

Package Label

The Treatment Formula 3(R)

ANTIFUNGAL
Professional

Formula 3(R) Brand Antifungal
Tolnaftate 1 percent Antifungal Solution

APPROVED
AMERICAN
PODIATRIC
MEDICAL
ASSOCIATION

Dispensed Only by Physicians

Professional Size: 1/2 oz (15ml)

Made in a USA, FDA Registered Laboratory

Questions or comments?
1-800-826-0479
Monday through Friday
9:00 AM to 6:00 PM Eastern Time

Manufactured for
THE TETRA CORPORATION
Eaton Rapids, MI 48827

Ask your Doctor about FungiFoam(R)

See Instructions Below

Application Instructions

Apply twice daily over affected area with brush or as directed by your doctor. If you have any questions, contact your doctor before beginning use of this product. Continue treatment until your next doctor's appointment. Only use this product under the direction of a physician.

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outer label

outer inner label

FORMULA 3 
tolnaftate solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49406-003
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (TOLNAFTATE) TOLNAFTATE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
RICE BRAN OIL 
SAFFLOWER OIL 
JOJOBA OIL 
.ALPHA.-TOCOPHEROL ACETATE 
METHYLPARABEN 
PROPYLPARABEN 
BUTYLPARABEN 
Packaging
#Item CodePackage Description
1NDC:49406-003-1515 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C10/30/2012
Labeler - The Tetra Corporation (829958409)
Registrant - Elba, Inc. (108428483)
Establishment
NameAddressID/FEIBusiness Operations
Elba, Inc.108428483manufacture(49406-003)

Revised: 06/2013
 
The Tetra Corporation