derman antifungal powder spray

derman antifungal powder spray
SPL v3
SPL
SPL Set ID 5784a783-1056-4d50-8d87-2df4f8e16b09
Route
topical
Published
Effective Date 2025-11-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
tolnaftate (10 mg)
Inactive Ingredients
alcohol butylated hydroxytoluene starch, corn isobutane kaolin ppg-12-buteth-16

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-11-13

Purpose

Antifungal

Description

Tolnaftate 1%


Medication Information

Warnings

For external use only

Flammable: Contents under pressure. Do not puncture or incinetare or store at a temperature above 120°F. Use only as directed. Intentional misuse by deliberately concentrating and inhaling aerosol products can be harmful or fatal. Do not use near flame or spark or white smoking.

Uses

Proven clinically effective in the treatment of most:

• Athlete's foot (tinea pedis) • Jock itch (tinea cruris) • Ringworm (tinea corporis)

Clinically proven to prevent most athlete's foot with daily use Relieves • itching • cracking • burning • scaling

Purpose

Antifungal

Directions

• clean the affected area and dry thoroughly

• shake can well before use: hold can about 6 inches from the area to be treated

• apply a thin layer over the affected area twice daily (morning and night), or as directed by a doctor

• supervise children in the use of this product

• use daily for 4 weeks for athlete's foot and ringworm; use daily for 2 weeks for jock itch

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

• if condition persists longer, consult a doctor

• this product is not effective on the scalp or nails

• 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

Other Information

store between 20° and 30°C (68° and 86°F)

Inactive Ingredients

BHT, Corn Starch, Isobutane, Kaolin, PPG-12-Buteth-16, SD Alcohol 40-B

Description

Tolnaftate 1%

Do Not Use

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

Drug Facts

Active Ingredient

Tolnaftate 1%

Package Labeling:

Questions Or Comments?

Call 1-855-289-3205 (toll-free) or email [email protected]

When Using This Product

avoid contact with the eyes

Stop Use and Ask A Doctor

if irritation occurs or if there is no improvement whithin 4 weeks (for athlete's foot or ringworm) or within 2 weeks (for jock itch)

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: Contents under pressure. Do not puncture or incinetare or store at a temperature above 120°F. Use only as directed. Intentional misuse by deliberately concentrating and inhaling aerosol products can be harmful or fatal. Do not use near flame or spark or white smoking.

Uses

Proven clinically effective in the treatment of most:

• Athlete's foot (tinea pedis) • Jock itch (tinea cruris) • Ringworm (tinea corporis)

Clinically proven to prevent most athlete's foot with daily use Relieves • itching • cracking • burning • scaling

Purpose

Antifungal

Directions

• clean the affected area and dry thoroughly

• shake can well before use: hold can about 6 inches from the area to be treated

• apply a thin layer over the affected area twice daily (morning and night), or as directed by a doctor

• supervise children in the use of this product

• use daily for 4 weeks for athlete's foot and ringworm; use daily for 2 weeks for jock itch

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

• if condition persists longer, consult a doctor

• this product is not effective on the scalp or nails

• 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

Other Information (Other information)

store between 20° and 30°C (68° and 86°F)

Inactive Ingredients (Inactive ingredients)

BHT, Corn Starch, Isobutane, Kaolin, PPG-12-Buteth-16, SD Alcohol 40-B

Do Not Use (Do not use)

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

Drug Facts

Active Ingredient (Active ingredient)

Tolnaftate 1%

Package Labeling:

Questions Or Comments? (Questions or comments?)

Call 1-855-289-3205 (toll-free) or email [email protected]

When Using This Product (When using this product)

avoid contact with the eyes

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

if irritation occurs or if there is no improvement whithin 4 weeks (for athlete's foot or ringworm) or within 2 weeks (for jock itch)

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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