derman antifungal powder spray tolnaftate

derman antifungal powder spray tolnaftate
SPL v4
SPL
SPL Set ID 3a854765-740c-4719-8abf-4b3f932cdee0
Route
topical
Published
Effective Date 2021-09-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
otc monograph drug completed Since 2022-05-01 Until 2028-11-30

Purpose

Antifungal

Description

Tolnaftate 1%


Medication Information

Warnings

For external use only

 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. Flammable:

Uses

Proven clinically effective in the treatment of most:

Clinically proven to prevent most athlete's foot with daily use Relieves

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

Active Ingredient

Tolnaftate 1%

Package Labeling:

When Using This Product

avoid contact with the eyes

Stop Use and Ask A Doctor 

if irritation occurs or if there is no improvement within 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

 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. Flammable:

Uses

Proven clinically effective in the treatment of most:

Clinically proven to prevent most athlete's foot with daily use Relieves

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

Active Ingredient (Active ingredient)

Tolnaftate 1%

Package Labeling:

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 within 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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