Luxury Athlete's Foot Powder Spray

Luxury Athlete's Foot Powder Spray
SPL v2
SPL
SPL Set ID 61ded99e-970e-4c61-8b61-1cac61e309da
Route
TOPICAL
Published
Effective Date 2021-03-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (1.3 g)
Inactive Ingredients
Butane Isobutylene Trolamine Starch, Corn Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2021-03-10

Description

Tolnaftate 1%

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Tolnaftate 1%

Uses
  • proven clinically effective in the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis)
  • helps prevents most athlete's foot with daily use
  • for effective relief of itching, cracking and burning
Warnings

For external use only.

Directions
  • shake can well and spray a thin layer over affected area twice daily (morning and night)
  • wash affected area and dry thoroughly
  • hold can 4-6 inches away from affected area
  • 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 condition persists longer, ask a doctor
  • if condition persists longer, consult a doctor
  • this product is not effective on the scalp or nails
  • in case of  clogging , clean nozzle with a pin
Do Not Use

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

Active Ingredient

Tolnaftate 1%

Other Information
  • store between 20° and 25°C (68° and 77°F)
Extremely Flammable:

Do not use while smoking or near heat or flame 

Inactive Ingredients

Alcohol denat, Butane , Isobutene , Triethanolamine , zea mays (corn) starch.

Principal Display Panel

When Using This Product
  • avoid contact with the eyes 
  • use only as directed. intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal
  • contents under pressure. Do not puncture or incinerate. Do not store temperature above 120 F (49 C)
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

Uses
  • proven clinically effective in the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis)
  • helps prevents most athlete's foot with daily use
  • for effective relief of itching, cracking and burning
Purpose

Antifungal

Warnings

For external use only.

Directions
  • shake can well and spray a thin layer over affected area twice daily (morning and night)
  • wash affected area and dry thoroughly
  • hold can 4-6 inches away from affected area
  • 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 condition persists longer, ask a doctor
  • if condition persists longer, consult a doctor
  • this product is not effective on the scalp or nails
  • in case of  clogging , clean nozzle with a pin
Do Not Use (Do not use)

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

Active Ingredient

Tolnaftate 1%

Other Information (Other information)
  • store between 20° and 25°C (68° and 77°F)
Extremely Flammable: (Extremely flammable:)

Do not use while smoking or near heat or flame 

Inactive Ingredients (Inactive ingredients)

Alcohol denat, Butane , Isobutene , Triethanolamine , zea mays (corn) starch.

Principal Display Panel

When Using This Product (When using this product)
  • avoid contact with the eyes 
  • use only as directed. intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal
  • contents under pressure. Do not puncture or incinerate. Do not store temperature above 120 F (49 C)
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.


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