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

Purpose

Anti-Fungal

Description

Tolnaftate 1%


Medication Information

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

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

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

Tolnaftate 1%

Packaging

Active Ingredient

Tolnaftate 1%

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

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

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

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

Active Ingredient

Tolnaftate 1%

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


Advanced Ingredient Data


Raw Label Data

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