Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID 570ee9fb-a495-4a99-9215-0cd1bb2e0290
Route
TOPICAL
Published
Effective Date 2024-11-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (1 g)
Inactive Ingredients
Cetostearyl Alcohol Glycerin Glyceryl Monostearate Petrolatum Propylene Glycol Sodium Sulfite Steareth-20 Stearic Acid Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-12-10

Description

Active ingredient Tolnaftate 1.0%


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

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

Dosage and Administration

Directions

Adults and children 2 years of age or older:


   wash the affected area and dry thoroughly


   apply a thin layer of the product over the 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


      change shoes and socks at least once daily

   use daily for 4 weeks for the treatment of athlete’s foot and ringworm

      if condition persists longer, consult a doctor

      use daily for the prevention of athlete’s foot


   this product is not effective on the scalp or nails

Children under 2 years: do not use unless directed by a doctor

Description

Active ingredient Tolnaftate 1.0%

Section 44425-7

Other information

keep container tightly closed


store between 15 and 30 C (59 to 86 F)

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 50570-1

Do not use


on children under 2 years of age unless directed by a doctor

Section 51727-6

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

Section 51945-4

SKINHEAL ANTIFUNGAL CREAM

Tolnaftate 1%

Net Wt. 10 g (1/3 oz)

NDC 69070-305-01

Section 53413-1

Questions or comments? (888) 221-3496 M-F 9am-5pm

you may also report serious side effects to this phone number

Section 55105-1

Purpose

Antifungal

Section 55106-9

Active ingredient

Tolnaftate 1.0%


Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

Directions

Adults and children 2 years of age or older:


   wash the affected area and dry thoroughly


   apply a thin layer of the product over the 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


      change shoes and socks at least once daily

   use daily for 4 weeks for the treatment of athlete’s foot and ringworm

      if condition persists longer, consult a doctor

      use daily for the prevention of athlete’s foot


   this product is not effective on the scalp or nails

Children under 2 years: do not use unless directed by a doctor

Warnings and Precautions (34071-1)

Warnings

For external use only

Section 44425-7 (44425-7)

Other information

keep container tightly closed


store between 15 and 30 C (59 to 86 F)

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 50570-1 (50570-1)

Do not use


on children under 2 years of age unless directed by a doctor

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

SKINHEAL ANTIFUNGAL CREAM

Tolnaftate 1%

Net Wt. 10 g (1/3 oz)

NDC 69070-305-01

Section 53413-1 (53413-1)

Questions or comments? (888) 221-3496 M-F 9am-5pm

you may also report serious side effects to this phone number

Section 55105-1 (55105-1)

Purpose

Antifungal

Section 55106-9 (55106-9)

Active ingredient

Tolnaftate 1.0%


Advanced Ingredient Data


Raw Label Data

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