Tolnaftate Cream 1%

Tolnaftate Cream 1%
SPL v5
SPL
SPL Set ID 3abfd734-229b-1a0e-e054-00144ff88e88
Route
TOPICAL
Published
Effective Date 2016-08-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (10 mg)
Inactive Ingredients
Cetostearyl Alcohol Stearyl Alcohol Light Mineral Oil Sodium Lauryl Sulfate Water Ethylparaben Glyceryl Monostearate Petrolatum Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-08-23

Description

Tolnaftate 1%

Purpose

Anti-Fungal


Medication Information

Purpose

Anti-Fungal

Description

Tolnaftate 1%

Uses
  • Proven clinically effective in the treatment of most athlete's foot (tinea pedis), and ringworm (tinea corporis)
  • Helps prevent most athlete's foot with daily use
  • For effective relief of itching, burning, and cracking
Warnings

For External Use Only

When using this product avoid contact with the eyes

Do not use on children under 2 years of age except under the advice and supervision of a doctor

Packaging

Directions
  • Wash affected area and dry thoroughly
  • Apply a thin 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 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
  • To prevent athlete's foot, apply once or twice daily (morning and/or night)
  • This product is not effective on the scalp or nails
Active Ingredient

Tolnaftate 1%

Other Information
  • Store between 20° to 25°C (68° to 77°F)
  • Lot No & Expiration Date: See box or crimp of tube
Inactive Ingredients:

Cetyl alcohol, Ethylparabe, Glycerol, Glyceryl Monostearate, Mineral Oil, Petrolatum, Purified Water, Sodium Dodecyl sulfate

Stop Use and Ask A Doctor If
  • irritation occurs
  • there is no improvement within 4 weeks
Keep Out of the Reach of Children

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

Soothes Itching, Burning and Cracking

Distributed By:

Pharmacy Value Alliance, LLC.

407 East Lancaster Avenue, Wayne, PA. 19087 USA

www.emersongroup.com


Structured Label Content

Uses
  • Proven clinically effective in the treatment of most athlete's foot (tinea pedis), and ringworm (tinea corporis)
  • Helps prevent most athlete's foot with daily use
  • For effective relief of itching, burning, and cracking
Purpose

Anti-Fungal

Warnings

For External Use Only

When using this product avoid contact with the eyes

Do not use on children under 2 years of age except under the advice and supervision of a doctor

Packaging

Directions
  • Wash affected area and dry thoroughly
  • Apply a thin 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 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
  • To prevent athlete's foot, apply once or twice daily (morning and/or night)
  • This product is not effective on the scalp or nails
Active Ingredient

Tolnaftate 1%

Other Information
  • Store between 20° to 25°C (68° to 77°F)
  • Lot No & Expiration Date: See box or crimp of tube
Inactive Ingredients: (Inactive ingredients:)

Cetyl alcohol, Ethylparabe, Glycerol, Glyceryl Monostearate, Mineral Oil, Petrolatum, Purified Water, Sodium Dodecyl sulfate

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

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

Soothes Itching, Burning and Cracking

Distributed By:

Pharmacy Value Alliance, LLC.

407 East Lancaster Avenue, Wayne, PA. 19087 USA

www.emersongroup.com


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