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

Purpose

Antifungal

Description

Tolnaftate 1%


Medication Information

Warnings

For external use only

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

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

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

Other Information

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

Inactive Ingredients

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

Description

Tolnaftate 1%

Do Not Use

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

Package Label

Active Ingredient

Tolnaftate 1%

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

Warnings

For external use only

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

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

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

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

Do Not Use (Do not use)

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

Package Label

Active Ingredient

Tolnaftate 1%

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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