Signature Care Antifungal Cream 0.5 Oz Tolnaftate 1% 78805 (2021) Zdp

Signature Care Antifungal Cream 0.5 Oz Tolnaftate 1% 78805 (2021) Zdp
SPL v6
SPL
SPL Set ID b02b81d6-8db4-927b-e053-2995a90a3958
Route
TOPICAL
Published
Effective Date 2021-07-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-01-04

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 of the product over affected area twice daily (morning and night) or as directed by a doctor
  • 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
  • for athlete's foot and ringworm, use daily for 4 weeks. If conditions persists longer, consult 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 Better Living Brands LLC

P.O. Box 99, Pleasanton, CA 94566

1-888-723-3929

Made in China

Description

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

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) 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 50570-1

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

Section 51727-6

Inactive ingredients cetostearyl alcohol, ethylparaben, glycerin, glyceryl, monostearate, petrolatum, propylene glycol, purified water, sodium sulfite, steareth-20, stearic acid

Section 51945-4

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

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 of the product over affected area twice daily (morning and night) or as directed by a doctor
  • 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
  • for athlete's foot and ringworm, use daily for 4 weeks. If conditions persists longer, consult 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 Better Living Brands LLC

P.O. Box 99, Pleasanton, CA 94566

1-888-723-3929

Made in China

Warnings and Precautions (34071-1)

Warnings

For external use only

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) 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 50570-1 (50570-1)

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

Section 51727-6 (51727-6)

Inactive ingredients cetostearyl alcohol, ethylparaben, glycerin, glyceryl, monostearate, petrolatum, propylene glycol, purified water, sodium sulfite, steareth-20, stearic acid

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

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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