Family Care Tolnaftate Cream 1 Oz 502

Family Care Tolnaftate Cream 1 Oz 502
SPL v7
SPL
SPL Set ID 6301ab99-1757-144a-e053-2a91aa0adb77
Route
TOPICAL
Published
Effective Date 2017-01-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (10 mg)
Inactive Ingredients
Glyceryl Monostearate Petrolatum Stearic Acid Propylene Glycol Water Sulfite Ion Steareth-20 Glycerin Cetostearyl Alcohol Ethylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-01-02

Description

Active ingredient Purpose Tolnaftate 1%..................................................................Antifungal


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

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; 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:

United Exchange Corp.

5836 Corporate Ave.

Cypress, CA 90630 USA

1-800-814-8028

Made in China

Description

Active ingredient Purpose Tolnaftate 1%..................................................................Antifungal

Section 44425-7

Other information

  • store between 20° to 25°C (68° to 77°F)
  • Lot No. & Exp. Date: see box or see crimp of tube
Section 50565-1

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

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

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

cetostearly alcohol, ethylparaben, glycerin, light mineral oil, propylene glycol, purified water, sodium sulfite, stearth-20, stearic acid

Section 51945-4

Section 55105-1

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
Section 55106-9

Active ingredient Purpose

Tolnaftate 1%..................................................................Antifungal


Structured Label Content

Indications and Usage (34067-9)

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; 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:

United Exchange Corp.

5836 Corporate Ave.

Cypress, CA 90630 USA

1-800-814-8028

Made in China

Warnings and Precautions (34071-1)

Warnings

For external use only

Section 44425-7 (44425-7)

Other information

  • store between 20° to 25°C (68° to 77°F)
  • Lot No. & Exp. Date: see box or see crimp of tube
Section 50565-1 (50565-1)

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

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

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

cetostearly alcohol, ethylparaben, glycerin, light mineral oil, propylene glycol, purified water, sodium sulfite, stearth-20, stearic acid

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

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
Section 55106-9 (55106-9)

Active ingredient Purpose

Tolnaftate 1%..................................................................Antifungal


Advanced Ingredient Data


Raw Label Data

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