Cr-371059 Tolnaftate 1% Cream

SPL v5

SPL

SPL Set ID bb4e4612-850c-4863-954d-7ad0500b9c05

Route

TOPICAL

Published

Effective Date 2023-11-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Tolnaftate (1 g)

Inactive Ingredients

Ceteth-20 Mineral Oil Chlorocresol Cetostearyl Alcohol Propylene Glycol Sodium Phosphate, Monobasic, Dihydrate Petrolatum

Identifiers & Packaging

Pill Appearance

Shape: freeform

Marketing Status

OTC MONOGRAPH DRUG Active Since 2021-03-01

Description

Tolnaftate 1%

Purpose

Antifungal

How Supplied

Product: 50090-6147 NDC: 50090-6147-0 14.8 g in a TUBE

Medication Information

Purpose

Antifungal

How Supplied

Product: 50090-6147

NDC: 50090-6147-0 14.8 g in a TUBE

Description

Tolnaftate 1%

Uses

• Proven effective in the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis)

• Helps prevent most athlete's foot with daily use

• For effective relief of itching, burning, and cracking

Warnings

• For External Use Only

• This product is not effective on the scalp or nails

Directions

• Wash affected area and dry thoroughly

• Apply a thin layer over affected area twice daily (morning and night)

• 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

• Use daily for 4 weeks; if condition persists longer, ask a doctor

• To prevent athlete's foot, apply once or twice daily (morning and/or night)

Tolnaftate

Active Ingredient

Tolnaftate 1%

Other Information

Store between 20° to 25ºC (68º to 77ºF)

Inactive Ingredients

Ceteth-20, Cetostearyl Alcohol, Chlorocresol, Mineral Oil, Propylene Glycol, Sodium Phosphate Dihydrate, White Soft Paraffin (Petrolatum)

Questions and Comments?

1-800-645-2158

When Using This Product

Avoid contact with the eyes

Stop Use and Ask A Doctor If

• Irritation occurs

• There is no improvement within 4 weeks

Keep Out of Reach of Children

• If swallowed, get medical help or contact a Poisen Control Center (1-800-222-1222) right away

• Do not use on children under 2 years of age except under the advice and supervision of a doctor

Structured Label Content

Uses

• Proven effective in the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis)

• Helps prevent most athlete's foot with daily use

• For effective relief of itching, burning, and cracking

Purpose

Antifungal

Warnings

• For External Use Only

• This product is not effective on the scalp or nails

Directions

• Wash affected area and dry thoroughly

• Apply a thin layer over affected area twice daily (morning and night)

• 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

• Use daily for 4 weeks; if condition persists longer, ask a doctor

• To prevent athlete's foot, apply once or twice daily (morning and/or night)

Tolnaftate (TOLNAFTATE)

How Supplied (HOW SUPPLIED)

Product: 50090-6147

NDC: 50090-6147-0 14.8 g in a TUBE

Active Ingredient

Tolnaftate 1%

Other Information

Store between 20° to 25ºC (68º to 77ºF)

Inactive Ingredients

Ceteth-20, Cetostearyl Alcohol, Chlorocresol, Mineral Oil, Propylene Glycol, Sodium Phosphate Dihydrate, White Soft Paraffin (Petrolatum)

Questions and Comments?

1-800-645-2158

When Using This Product (When using this product)

Avoid contact with the eyes

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

• Irritation occurs

• There is no improvement within 4 weeks

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

• If swallowed, get medical help or contact a Poisen Control Center (1-800-222-1222) right away

• Do not use on children under 2 years of age except under the advice and supervision of a doctor

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "• Proven effective in the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis) • Helps prevent most athlete's foot with daily use • For effective relief of itching, burning, and cracking", "Purpose": "Antifungal", "Warnings": "• For External Use Only • This product is not effective on the scalp or nails", "Directions": "• Wash affected area and dry thoroughly • Apply a thin layer over affected area twice daily (morning and night) • 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 • Use daily for 4 weeks; if condition persists longer, ask a doctor • To prevent athlete's foot, apply once or twice daily (morning and/or night)", "HOW SUPPLIED": "Product: 50090-6147 NDC: 50090-6147-0 14.8 g in a TUBE", "Active Ingredient": "Tolnaftate 1%", "Other Information": "Store between 20° to 25ºC (68º to 77ºF)", "Inactive Ingredients": "Ceteth-20, Cetostearyl Alcohol, Chlorocresol, Mineral Oil, Propylene Glycol, Sodium Phosphate Dihydrate, White Soft Paraffin (Petrolatum)", "Questions and Comments?": "1-800-645-2158", "When using this product": "Avoid contact with the eyes", "Stop use and ask a doctor if": "• Irritation occurs • There is no improvement within 4 weeks", "Keep out of reach of children": "• If swallowed, get medical help or contact a Poisen Control Center (1-800-222-1222) right away • Do not use on children under 2 years of age except under the advice and supervision of a doctor"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:11.606845 · Updated: 2026-03-14T23:01:38.303933