Your browser does not support JavaScript! FORMULA 3 (TOLNAFTATE) SOLUTION [THE TETRA CORPORATION]
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FORMULA 3 (tolnaftate) solution
[The Tetra Corporation]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

FORMULA 3

Active ingredient:

Tolnaftate 1%

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, Methyl Paraben, Propyl Paraben and Butyl Paraben.

FORMULA 3 BRAND Antifungal Tolnaftate 1% Antifungal Solution 15ml (49406-003-15)

Representative Labeling

outer label

outer inner label

inner label

FORMULA 3  
tolnaftate solution
Product Information
Product TypeHUMAN OTC DRUG LABELItem 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
APRICOT KERNEL OIL 
RICE BRAN OIL 
SESAME OIL 
SAFFLOWER OIL 
JOJOBA OIL 
.ALPHA.-TOCOPHEROL ACETATE 
METHYLPARABEN 
PROPYLPARABEN 
BUTYLPARABEN 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
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 Laboratories (108428483)
Establishment
NameAddressID/FEIBusiness Operations
Elba Laboratories108428483manufacture(49406-003)

Revised: 1/2014
 
The Tetra Corporation

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