quality choice antifungal cream tolnaftate 1%

quality choice antifungal cream tolnaftate 1%
SPL v3
SPL
SPL Set ID acdbebf1-319d-dfe9-e053-2995a90ad430
Route
topical
Published
Effective Date 2020-08-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
tolnaftate (1 g)
Inactive Ingredients
mineral oil ethylparaben glycerin sodium lauryl sulfate glyceryl monostearate petrolatum water cetyl alcohol

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2020-08-14

Purpose

Antifungal

Description

Tolnaftate 1%


Medication Information

Warnings

For external use only.

When using this product avoid contact with the eyes.

Stop use and ask a doctorl if ● irritation occurs ● there is no improvement within 4 weeks improvement

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

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

● 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 conditions persists 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.

Other Information

● store between 20° to 25°C ( 68° to 77°F) ● Lot No & Expiration Date: See box or crimp of tube.

Inactive Ingredients

Cetyl alcohol, ethylparaben, glycerol, mineral oil, glycerol monostearate, petrolatum, purified water, sodium lauryl sulfate

Description

Tolnaftate 1%

Section 51945-4

Drug Facts

Distributed By

Distributed By CDMA Inc.

43157 W 9 Mile Road

Novi, MI. 48375

www.qualitychoice.com

Questions: 800-935-2362

Product of PRC

This product is not manufactured or distributed by Bayer Health Care, LLC. distributor of Tinactin Antifungal Cream

Active Ingredient

Tolnaftate 1%

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center immediately.


Structured Label Content

Warnings

For external use only.

When using this product avoid contact with the eyes.

Stop use and ask a doctorl if ● irritation occurs ● there is no improvement within 4 weeks improvement

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

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

● 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 conditions persists 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.

Other Information (Other information)

● store between 20° to 25°C ( 68° to 77°F) ● Lot No & Expiration Date: See box or crimp of tube.

Inactive Ingredients (Inactive ingredients)

Cetyl alcohol, ethylparaben, glycerol, mineral oil, glycerol monostearate, petrolatum, purified water, sodium lauryl sulfate

Section 51945-4 (51945-4)

Drug Facts

Distributed By

Distributed By CDMA Inc.

43157 W 9 Mile Road

Novi, MI. 48375

www.qualitychoice.com

Questions: 800-935-2362

Product of PRC

This product is not manufactured or distributed by Bayer Health Care, LLC. distributor of Tinactin Antifungal Cream

Active Ingredient (Active ingredient)

Tolnaftate 1%

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

If swallowed, get medical help or contact a Poison Control Center immediately.


Advanced Ingredient Data


Raw Label Data

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