FORMULA 7 THEGEL- tolnaftate gel 
The Tetra Corporation

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Formula 7 THE GEL

Uses:

Antifungal 

For effective treatment of most athlete’s foot and ringworm.
Relieves:

• Itching

• Scaling

• Cracking
• Redness

• Soreness

• Burning

• Irritation

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

Active ingredient

Tolnaftate 1%

Stop use and ask a doctor if:

• When using for treatment of 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.

DO NOT USE SECTION

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

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feedingask a health professional before use.

Questions or comments?

1-800-826-0479
9:00 AM to 5:30 PM EST.

Inactive Ingredients

Inactive Ingredients: Water (aqua),C12-15 Alkyl Benzoate, SimmondsiaChinensis (Jojoba) Oil, Glycerin,Oleth-10, Oleth-5, Oleth-3 Phosphate,PEG-20 Hydrogenated Lanolin,Butylene Glycol, Urea, Ethoxydiglycol,N-Acetyl-L-Cysteine, TocopherolAcetate (Vitamin E), Melaleuca
Alternifolia (Tea Tree) Oil, DisodiumEDTA, Ethylhexylglycerin, CaprylylGlycol, Phenoxyethanol, Aminomethylpropanediol,Sodium Chloride.

Directions:

For treatment of athlete’s foot and ringworm:

• Clean the affected area and dry thoroughly. Apply a thin layer of the product over the 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 the scalp or nails.

To prevent athlete’s foot:
• Wash 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.

Other information

Store at room temperature, 25ºC (77ºF).

Warnings

For external use only.

When using this product avoid contact with eyes.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Product Label

Label

FORMULA 7 THEGEL 
tolnaftate gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49406-008
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
JOJOBA OIL (UNII: 724GKU717M)  
GLYCERIN (UNII: PDC6A3C0OX)  
OLETH-10 (UNII: JD797EF70J)  
OLETH-5 (UNII: 1GH33785AY)  
OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)  
PEG-20 HYDROGENATED LANOLIN (UNII: 5PP3KJ4T6S)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
UREA (UNII: 8W8T17847W)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TEA TREE OIL (UNII: VIF565UC2G)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ACETYLCYSTEINE (UNII: WYQ7N0BPYC)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49406-008-3015 g in 1 PACKAGE; Type 0: Not a Combination Product06/13/2018
2NDC:49406-008-2828 g in 1 JAR; Type 0: Not a Combination Product01/28/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00506/13/2018
Labeler - The Tetra Corporation (829958409)
Registrant - The Tetra Corporation (829958409)

Revised: 10/2023
Document Id: 0786f8cb-fb97-0851-e063-6394a90a2334
Set id: 6f5eb8ea-ce5a-4553-9d51-a4be03dd0470
Version: 5
Effective Time: 20231012
 
The Tetra Corporation