Winco Antifungal Tolnaftate 1% Cream 1 Oz (24193, 2018)

Winco Antifungal Tolnaftate 1% Cream 1 Oz (24193, 2018)
SPL v8
SPL
SPL Set ID 218f7613-1401-4f1b-bf46-576b536825af
Route
TOPICAL
Published
Effective Date 2017-05-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (10 mg)
Inactive Ingredients
Ceteth-20 Cetyl Alcohol Methylparaben Mineral Oil Propylene Glycol Propylparaben Sorbitan Monostearate Stearyl Alcohol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-02-06

Description

Active ingredient (in each gram)   Purpose Tolnaftate 1%--------------------------------------------------------------------------------- Antifungal


Medication Information

Warnings and Precautions

Warnings:

For external use only

Do not use on children under 2 years of age unless directed by a doctor

Indications and Usage

Directions

  • wash affected area and dry thoroguhly
  • 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
Dosage and Administration

DISTRIBUTED BY:

WINCO FOODS, LLC,

BOISE, ID 83704

MADE IN KOREA

Description

Active ingredient (in each gram)   Purpose Tolnaftate 1%--------------------------------------------------------------------------------- Antifungal

Section 50565-1

Keep out of reach of children

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

Section 50566-9

Stop use and ask a doctor if

  • irritation occurs
  • there is no improvement within 4 weeks
Section 50567-7

When using this product

Avoid contact with the eyes.

Section 51727-6

Inactive ingredients

buylated hydroxytoluene, ceteth-20, cetyl alcohol, methylparaben, mineral oil, propylene glycol, propylparaben, sorbitan monostearate, stearyl alcohol, water

Section 51945-4

Section 55105-1

Uses

  • Proven clinically effective in the treatment of athlete's foot (tinea pedis) and rignworm (tinea corporis)
  • Helps prevent most athlete's foot with daily use
  • For effective relief of itching, burning and cracking
Section 55106-9

Active ingredient (in each gram)   Purpose

Tolnaftate 1%--------------------------------------------------------------------------------- Antifungal

Section 60561-8

Other information

  • store between 20° to 25C° (68° to 77F°)
  • Lot No & Exp. Date: see box or see crimp of tube

Structured Label Content

Indications and Usage (34067-9)

Directions

  • wash affected area and dry thoroguhly
  • 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
Dosage and Administration (34068-7)

DISTRIBUTED BY:

WINCO FOODS, LLC,

BOISE, ID 83704

MADE IN KOREA

Warnings and Precautions (34071-1)

Warnings:

For external use only

Do not use on children under 2 years of age unless directed by a doctor

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 50566-9 (50566-9)

Stop use and ask a doctor if

  • irritation occurs
  • there is no improvement within 4 weeks
Section 50567-7 (50567-7)

When using this product

Avoid contact with the eyes.

Section 51727-6 (51727-6)

Inactive ingredients

buylated hydroxytoluene, ceteth-20, cetyl alcohol, methylparaben, mineral oil, propylene glycol, propylparaben, sorbitan monostearate, stearyl alcohol, water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Uses

  • Proven clinically effective in the treatment of athlete's foot (tinea pedis) and rignworm (tinea corporis)
  • Helps prevent most athlete's foot with daily use
  • For effective relief of itching, burning and cracking
Section 55106-9 (55106-9)

Active ingredient (in each gram)   Purpose

Tolnaftate 1%--------------------------------------------------------------------------------- Antifungal

Section 60561-8 (60561-8)

Other information

  • store between 20° to 25C° (68° to 77F°)
  • Lot No & Exp. Date: see box or see crimp of tube

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)