SPL v5
SPL
SPL Set ID c01e1ec7-045b-4a32-abb5-9f624468ade7
Route
TOPICAL
Published
Effective Date 2015-09-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (1 g)
Inactive Ingredients
Alcohol Isobutane Propane Butane Talc

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2010-05-21

Description

Tolnaftate 1%

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Tolnaftate 1%

Uses
  • cures most athlete's foot (tinea pedis) and ringworm (tinea corporis)
  • if used daily, can prevent recurrence of athlete's foot
  • relieves symptoms of athlete's foot, including itching, burning and cracking

Warnings

For external use only

Flammable. Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure Do not store in temperature above 120°F (49°C).

Directions
  • wash affected area and dry thoroughly
  • shake can well and spray a this 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 the spaces between the toes, wear well-fitting, ventilated shoes and change shoes and socks at least once day.
  • use daily for 4 weeks; if condition persists longer, consult a doctor
  • to prevent athlete's foot, apply once or twice daily (morning and night)
  • in case of clogging, clean nozzle with a pin

Other Information

store between 68° to 77°F (20° to 25°C)

Inactive Ingredients

alcohol, isobutane, perfume, propane, n-butane, talc powder.

When Using This Product
  • avoid contact eyes and face
  • use only as directed. Intentional misuse by deliberately concentrating and inhaling contents can be harmfl or fatal.

Drug Facts Active Ingredient

Tolnaftate 1%

Stop Use and Ask A Doctor If
  • irritation occurs
  • there is no improvement after 4 weks

Keep Out of Reach of Children

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately. Do not use on children under 2 years of age unless directed by a doctor.

Anti Fungal Powder Spray Label

PERSONAL CARE®

ANTIFUNGAL POWDER SPRAY

For Athlete's Foot

TOLNAFTATE 1%

*Compare to the Active Ingredients in Tinactin®

Cures and Prevents Most Athlete's Foot

Relieves Itching and Burning

*This product is not manufactured ir distributed by Schering-Plough HealthCare Products, Inc., owner of the registered trademark Tinactin®

Distributed by: Personal Care Products, Inc. Bingham Farms, MI 48025-3463

Made in China




Structured Label Content

Uses
  • cures most athlete's foot (tinea pedis) and ringworm (tinea corporis)
  • if used daily, can prevent recurrence of athlete's foot
  • relieves symptoms of athlete's foot, including itching, burning and cracking

Purpose

Antifungal

Warnings

For external use only

Flammable. Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure Do not store in temperature above 120°F (49°C).

Directions
  • wash affected area and dry thoroughly
  • shake can well and spray a this 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 the spaces between the toes, wear well-fitting, ventilated shoes and change shoes and socks at least once day.
  • use daily for 4 weeks; if condition persists longer, consult a doctor
  • to prevent athlete's foot, apply once or twice daily (morning and night)
  • in case of clogging, clean nozzle with a pin

Other Information (Other information)

store between 68° to 77°F (20° to 25°C)

Inactive Ingredients (Inactive ingredients)

alcohol, isobutane, perfume, propane, n-butane, talc powder.

When Using This Product (When using this product)
  • avoid contact eyes and face
  • use only as directed. Intentional misuse by deliberately concentrating and inhaling contents can be harmfl or fatal.

Drug Facts Active Ingredient (Drug Facts Active ingredient)

Tolnaftate 1%

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • irritation occurs
  • there is no improvement after 4 weks

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

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately. Do not use on children under 2 years of age unless directed by a doctor.

Anti Fungal Powder Spray Label (ANTI FUNGAL POWDER SPRAY Label)

PERSONAL CARE®

ANTIFUNGAL POWDER SPRAY

For Athlete's Foot

TOLNAFTATE 1%

*Compare to the Active Ingredients in Tinactin®

Cures and Prevents Most Athlete's Foot

Relieves Itching and Burning

*This product is not manufactured ir distributed by Schering-Plough HealthCare Products, Inc., owner of the registered trademark Tinactin®

Distributed by: Personal Care Products, Inc. Bingham Farms, MI 48025-3463

Made in China




Advanced Ingredient Data


Raw Label Data

All Sections (JSON)