Formula 7 THE GEL

Manufacturer
The Tetra Corporation
Effective date
2023-10-12
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:56:39

Label at a glance#

ProductFormula 7 THEGEL
Active ingredientTOLNAFTATE
Label structure13 sections

Indications and uses

Antifungal 

Dosage and administration

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. • ...

Storage and handling

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

Label contents#

Full prescribing information#

Uses:

OTC - PURPOSE SECTION

Antifungal 

INDICATIONS & USAGE SECTION

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

OTC - ACTIVE INGREDIENT SECTION

Tolnaftate 1%

Stop use and ask a doctor if:

OTC - ASK DOCTOR SECTION

• 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

OTC - DO NOT USE SECTION

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

PREGNANCY OR BREAST FEEDING

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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:

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

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

Warnings

WARNINGS SECTION

For external use only.

When using this product avoid contact with eyes.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
313420tolnaftate 1 % Topical GelPSN5
313420tolnaftate 0.01 MG/MG Topical GelSCD5
313420tolnaftate 1 % Topical GelSY5

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7b19f89e-0a13-4d4e-a994-a46d39d008b9Product name120251120
13c3e0af-2da2-8aec-9e17-1afd680d80c2Product name820221116
f46c867f-cde5-4f14-a7c1-18ae3a6efd1cProduct name120160303

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49406-008-28Formula 7 THEGEL28 g in 1 JARGEL285
49406-008-30Formula 7 THEGEL15 g in 1 PACKAGEGEL155

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49406-008FORMULA 7 THEGEL (TOLNAFTATE) GEL [THE TETRA CORPORATION]5Legacy NDC, 2 package rows20231013_6f5eb8ea-ce5a-4553-9d51-a4be03dd0470.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49406-00849406-008-30, 49406-008-28

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0786f8cb-fb97-0851-e063-6394a90a23346f5eb8ea-ce5a-4553-9d51-a4be03dd04702023-10-12WarningsExact identifier
spl id: 0786f8cb-fb97-0851-e063-6394a90a2334
spl set id: 6f5eb8ea-ce5a-4553-9d51-a4be03dd0470

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.