Drug Facts

Drug Facts
SPL v11
SPL
SPL Set ID 173b4c79-ff51-4358-b843-cf2419023173
Route
TOPICAL
Published
Effective Date 2018-12-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (0.1 g)
Inactive Ingredients
Alcohol Starch, Corn Butylated Hydroxytoluene Isobutane Kaolin Ppg-12-buteth-16

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2002-03-01

Description

Active Ingredients:             Purpose Tolnaftate 1% W/W........................ Antifungal


Medication Information

Warnings and Precautions


Warnings

For external use only

Flammable:Contents under pressure. Do not puncture or incinerate or store at a temperature above 120 degrees 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 while smoking.



Indications and Usage

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 dauly use

Relieves 

  • itching
  • cracking
  • burning
  • scaling
  • discomfort
Dosage and Administration

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

Athlete's Foot and Ringworm - use daily for 4 weeks

Jock Itch - use daily for 2 weeks

  • to prevent most athlete's foot, apply once or twice daily (morning and/or night)
  • this product is not effective on the scalp or nails

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 a day
Description

Active Ingredients:             Purpose Tolnaftate 1% W/W........................ Antifungal

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50570-1

Do not use on children under 2 years of age



When using this product avoid contact with 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)

Section 51727-6

Inactive ingredients Alcohol SD-40-B (14% w/w), BHT, PPG-12-Buteth-16, Kaolin, Zea Mays (Corn) Starch, Isobutane

Section 51945-4

Section 53413-1

Questions or comments?



Please Call 305-805-3456 (M-F 9:00-5:00 pm EST)

Section 55105-1

Purpose: Antifungal

Section 55106-9

Active Ingredients:             Purpose

Tolnaftate 1% W/W........................ Antifungal






Structured Label Content

Indications and Usage (34067-9)

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 dauly use

Relieves 

  • itching
  • cracking
  • burning
  • scaling
  • discomfort
Dosage and Administration (34068-7)

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

Athlete's Foot and Ringworm - use daily for 4 weeks

Jock Itch - use daily for 2 weeks

  • to prevent most athlete's foot, apply once or twice daily (morning and/or night)
  • this product is not effective on the scalp or nails

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 a day
Warnings and Precautions (34071-1)


Warnings

For external use only

Flammable:Contents under pressure. Do not puncture or incinerate or store at a temperature above 120 degrees 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 while smoking.



Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50570-1 (50570-1)

Do not use on children under 2 years of age



When using this product avoid contact with 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)

Section 51727-6 (51727-6)

Inactive ingredients Alcohol SD-40-B (14% w/w), BHT, PPG-12-Buteth-16, Kaolin, Zea Mays (Corn) Starch, Isobutane

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments?



Please Call 305-805-3456 (M-F 9:00-5:00 pm EST)

Section 55105-1 (55105-1)

Purpose: Antifungal

Section 55106-9 (55106-9)

Active Ingredients:             Purpose

Tolnaftate 1% W/W........................ Antifungal






Advanced Ingredient Data


Raw Label Data

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