Antifungal Powder Spray

Antifungal Powder Spray
SPL v1
SPL
SPL Set ID 9f69c16d-81c3-93e0-e053-2a95a90a4bc4
Route
TOPICAL
Published
Effective Date 2018-02-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (1 g)
Inactive Ingredients
Alcohol Butane Propane Trolamine Starch, Corn

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2018-02-19

Description

Tolnaftate 1%

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Tolnaftate 1%

Uses

■ proven clinically 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

Flammable: Do not use while smoking or near heat or flame

Directions

■ wash affected area and dry thoroughly ■ shake can well and spray 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 a day ■ use daily for 4 weeks, if conditions persist longer, ask a doctor ■ to prevent athlete's foot, apply once or twice daily (morning and/or night) ■ this product is not effective on the scalp or nails ■ in case of clogging, clean nozzle with pin

Do Not Use

on children under 2 years of age unless directed by a doctor

Package Label

Active Ingredient

Tolnaftate 1%

Other Information

■ store between 68º to 77ºF (20º to 25ºC)

Inactive Ingredients

alcohol denat., butane, fragrance, propane, triethanolamine, zea mays (corn) starch

When Using This Product

■ avoid contact with eyes ■ use only as directed. Intentional misuse by deliberetely concentrating and inhaling contents can be harmful or fatal ■ contents under pressure. Do not puncture or incinerate.

Do not stire at a temperature above 120ºF (49ºC​)

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 Poison Control Center right away


Structured Label Content

Uses

■ proven clinically 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

Flammable: Do not use while smoking or near heat or flame

Directions

■ wash affected area and dry thoroughly ■ shake can well and spray 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 a day ■ use daily for 4 weeks, if conditions persist longer, ask a doctor ■ to prevent athlete's foot, apply once or twice daily (morning and/or night) ■ this product is not effective on the scalp or nails ■ in case of clogging, clean nozzle with pin

Do Not Use (Do not use)

on children under 2 years of age unless directed by a doctor

Package Label

Active Ingredient

Tolnaftate 1%

Other Information (Other information)

■ store between 68º to 77ºF (20º to 25ºC)

Inactive Ingredients (Inactive ingredients)

alcohol denat., butane, fragrance, propane, triethanolamine, zea mays (corn) starch

When Using This Product (When using this product)

■ avoid contact with eyes ■ use only as directed. Intentional misuse by deliberetely concentrating and inhaling contents can be harmful or fatal ■ contents under pressure. Do not puncture or incinerate.

Do not stire at a temperature above 120ºF (49ºC​)

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 Poison Control Center right away


Advanced Ingredient Data


Raw Label Data

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