FORMULA 3- tolnaftate solution 
The Tetra Corporation

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FORMULA 3

FORMULA 3

Active ingredient:

Tolnaftate 1%

Purpose

Antifungal

Uses:

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

Relieves:

Prevents the recurrence of most athlete's foot (dermatophytosis) with daily use.


Warnings

For external use only.

Do not useon children under 2 years of age unless directed by a doctor.

When using this productavoid contact with eyes.

Stop use and ask a doctor if

If pregnant or breastfeedingask 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

To prevent athlete's foot:

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 DRUGItem Code (Source)NDC:49406-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
APRICOT KERNEL OIL (UNII: 54JB35T06A)  
RICE BRAN OIL (UNII: LZO6K1506A)  
SESAME OIL (UNII: QX10HYY4QV)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
JOJOBA OIL (UNII: 724GKU717M)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49406-003-151 in 1 BOX10/30/2012
115 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00510/30/2012
Labeler - The Tetra Corporation (829958409)
Registrant - The Tetra Corporation (829958409)

Revised: 10/2023
Document Id: 0786b213-548d-3c8f-e063-6394a90a9809
Set id: 0895274b-a09d-4264-a43f-852e44eb3163
Version: 19
Effective Time: 20231012
 
The Tetra Corporation