SPL v2
SPL
SPL Set ID afb6d7c4-1f75-4694-83c8-d6469250d6a1
Route
TOPICAL
Published
Effective Date 2025-08-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (1 g)
Inactive Ingredients
Water Jojoba Oil Glycerin Oleth-10 Oleth-3 Phosphate Oleth-5 Peg-20 Hydrogenated Lanolin Butylene Glycol Urea Alkyl (c12-15) Benzoate .alpha.-tocopherol Acetate Tea Tree Oil Ethylhexylglycerin Caprylyl Glycol Phenoxyethanol Acetylcysteine Aminomethylpropanol Sodium Chloride

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2018-06-13 Until 2018-06-13

Description

Antifungal 


Medication Information

Indications and Usage

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.

Description

Antifungal 

Uses:

Antifungal 

Section 50565-1

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

Warnings

For external use only. When using this product avoid contact with eyes.

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.

Product Label

Active Ingredient

Tolnaftate 1%

Other Information

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

Do Not Use Section

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

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.

Questions Or Comments?

1-800-826-0479

9:00 AM to 5:30 PM EST.

Pregnancy Or Breast Feeding

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

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.


Structured Label Content

Uses:

Antifungal 

Indications and Usage (34067-9)

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.

Section 50565-1 (50565-1)

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

Warnings

For external use only. When using this product avoid contact with eyes.

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.

Product Label (Product label)

Active Ingredient (Active ingredient)

Tolnaftate 1%

Other Information (Other information)

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

Do Not Use Section (DO NOT USE SECTION)

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

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.

Questions Or Comments? (Questions or comments?)

1-800-826-0479

9:00 AM to 5:30 PM EST.

Pregnancy Or Breast Feeding (PREGNANCY OR BREAST FEEDING)

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

Stop Use and Ask A Doctor If: (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.


Advanced Ingredient Data


Raw Label Data

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