Anti-fungal Powder

Anti-fungal Powder
SPL v2
SPL
SPL Set ID eb7eba3b-182d-4be9-971c-fde428b9eb5f
Route
TOPICAL
Published
Effective Date 2018-05-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (.45 g)
Inactive Ingredients
Starch, Corn Talc

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 1999-03-16

Description

Tolnaftate 1 %

Purpose

Antifungal


Medication Information

Indications and Usage

Uses

  • for effective treatment of most athlete's foot (tinea pedis) and jock itch (tinea cruris)
  • relieves itching, scaling, burning, irritation and discomfort
  • clears up most athlete's foot infection and, with daily use, helps to keep it from coming back
Purpose

Antifungal

Description

Tolnaftate 1 %

Warnings

For external use only

Do not use on children under 2 years of age.



When using this product avoid contact with the eyes



Stop use and ask a doctor if 

  • irritation occurs
  • there is no improvement within 4 weeks (for athlete's foot) or within 2 weeks (for jock itch)
Directions
  • shake well before use
  • clean the affected area and dry thoroughly
  • apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor
  • supervise children in the use of this product
  • this product is not effective on the scalp or nails

For athletes foot

  • use daily for 4 weeks 
  • pay special attention to the spaces between the toes
  • wear well-fitting, ventilated shoes
  • change shoes and socks at least once a daily
  • to prevent athlete's foot: clean and dry feet thoroughly, apply once or twice daily

For jock itch

  • use daily for 2 weeks
Active Ingredient

Tolnaftate 1 %

Other Information

store between 2° - 30° C (36° - 86° F)

Inactive Ingredients

starch, talc

Package Label Display

Keep Out of Reach of Children.



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


Structured Label Content

Indications and Usage (34067-9)

Uses

  • for effective treatment of most athlete's foot (tinea pedis) and jock itch (tinea cruris)
  • relieves itching, scaling, burning, irritation and discomfort
  • clears up most athlete's foot infection and, with daily use, helps to keep it from coming back
Purpose

Antifungal

Warnings

For external use only

Do not use on children under 2 years of age.



When using this product avoid contact with the eyes



Stop use and ask a doctor if 

  • irritation occurs
  • there is no improvement within 4 weeks (for athlete's foot) or within 2 weeks (for jock itch)
Directions
  • shake well before use
  • clean the affected area and dry thoroughly
  • apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor
  • supervise children in the use of this product
  • this product is not effective on the scalp or nails

For athletes foot

  • use daily for 4 weeks 
  • pay special attention to the spaces between the toes
  • wear well-fitting, ventilated shoes
  • change shoes and socks at least once a daily
  • to prevent athlete's foot: clean and dry feet thoroughly, apply once or twice daily

For jock itch

  • use daily for 2 weeks
Active Ingredient

Tolnaftate 1 %

Other Information (Other information)

store between 2° - 30° C (36° - 86° F)

Inactive Ingredients (Inactive ingredients)

starch, talc

Package Label Display

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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