Cr-371059 Tolnaftate 1% Cream

Cr-371059 Tolnaftate 1% Cream
SPL v6
SPL
SPL Set ID b95a76ad-9b4c-692a-e053-2995a90abd1a
Route
TOPICAL
Published
Effective Date 2021-03-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (1 g)
Inactive Ingredients
Ceteth-20 Mineral Oil Chlorocresol Propylene Glycol Sodium Phosphate, Monobasic, Dihydrate Petrolatum Cetostearyl Alcohol

Identifiers & Packaging

Pill Appearance
Shape: freeform
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-03-01

Description

Tolnaftate 1%

Purpose

Antifungal


Medication Information

Purpose

Antifungal

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

Label

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)

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

Label

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)

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


Raw Label Data

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