SPL v1
SPL
SPL Set ID 2e3cde7b-850e-f9d2-e063-6394a90adb18
Route
TOPICAL
Published
Effective Date 2025-02-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (1 g)
Inactive Ingredients
Euphorbia Hirta Whole Glycerin Hydracrylic Acid Resorcinol Water Pseudolarix Amabilis Bark

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-02-16

Description

Tolnaftate 1%

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Tolnaftate 1%

Dosage



For Athlete's foot and ring worm: use dailyfor 4 weeks. Clean the affected area and

drythoroughly. Apply a thin layer of the productover affected area twice daily (morning

andnight) or as directed by a doctor. Supervisechildren in the use of this product

Section 50566-9



Stop use and ask a doctor ifirritation occurs, there is no improvementwithin 4 weeks

(for athlete's foot andringworm).

Package

Warnings



Warnings

For external use only.Do not use on children under 2 years of ageunless directed by a

doctor.

Do Not Use

If irritation occurs, discontinue useand consult a doctor!

When Using

When using this product avoid contact with eyes.

Active Ingredient

Tolnaftate 1%

Directions for Use



For athlete's foot and ringworm: use dailyfor 4 weeks. Clean the affected area and

drythoroughly. Apply a thin layer of the productover affected area twice daily (morning

andnight) or as directed by a doctor. Supervisechildren in the use of this product.

Thisproduct is not effective for the treatment ofringworm of the scalp or nails. For

athlete'sfoot: pay special attention to spacesbetween the toes, wear well-fitting.ventilated

shoes, and change shoes andsocks at least once daily. To preventathlete's foot, apply

once or twice daily(morning and/ or night). Apply to skin aroundthe nail and cuticle.

Inactive Ingredlents



Euphorbia hirta whole, Glycerin,Hydracrylic acid, Pseudolarix amabilisbark,Resorcinol,

Water,

Keep Out of Reach of Children



lf swallowed, get medical help or contact aPoison Control Center(1-800-222-

1222)rightaway.


Structured Label Content

Dosage



For Athlete's foot and ring worm: use dailyfor 4 weeks. Clean the affected area and

drythoroughly. Apply a thin layer of the productover affected area twice daily (morning

andnight) or as directed by a doctor. Supervisechildren in the use of this product

Section 50566-9 (50566-9)



Stop use and ask a doctor ifirritation occurs, there is no improvementwithin 4 weeks

(for athlete's foot andringworm).

Purpose

Antifungal

Package (package)

Warnings



Warnings

For external use only.Do not use on children under 2 years of ageunless directed by a

doctor.

Do Not Use (Do not use)

If irritation occurs, discontinue useand consult a doctor!

When Using (When using)

When using this product avoid contact with eyes.

Active Ingredient

Tolnaftate 1%

Directions for Use (Directions for use)



For athlete's foot and ringworm: use dailyfor 4 weeks. Clean the affected area and

drythoroughly. Apply a thin layer of the productover affected area twice daily (morning

andnight) or as directed by a doctor. Supervisechildren in the use of this product.

Thisproduct is not effective for the treatment ofringworm of the scalp or nails. For

athlete'sfoot: pay special attention to spacesbetween the toes, wear well-fitting.ventilated

shoes, and change shoes andsocks at least once daily. To preventathlete's foot, apply

once or twice daily(morning and/ or night). Apply to skin aroundthe nail and cuticle.

Inactive Ingredlents (Inactive ingredlents)



Euphorbia hirta whole, Glycerin,Hydracrylic acid, Pseudolarix amabilisbark,Resorcinol,

Water,

Keep Out of Reach of Children (Keep out of reach of children)



lf swallowed, get medical help or contact aPoison Control Center(1-800-222-

1222)rightaway.


Advanced Ingredient Data


Raw Label Data

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