Tinactin ®

Tinactin ®
SPL v3
SPL
SPL Set ID 0beda157-efd2-5245-e063-6394a90a6911
Route
TOPICAL
Published
Effective Date 2023-11-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (10 mg)
Inactive Ingredients
Starch, Corn Isobutane Butylated Hydroxytoluene Ppg-12-buteth-16 Kaolin Magnesium Stearate Hydroxypropyl Cellulose, Unspecified

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-11-29

Description

Drug Facts

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Drug Facts

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 42229-5

Drug Facts

Section 50565-1

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

Section 51945-4

TOUGH ACTIN' ®



Tinactin ®

tolnaftate ANTIFUNGAL

Cures and prevents

most athlete's foot

Relieves

  • itching
  • burning

POWDER SPRAY

goes on dry

talc free

NET WT 133g (4.6 oz)

Warnings

For external use only

Flammable: Do not use near heat, flame, or while smoking

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

Directions
  • wash affected area and dry thoroughly
  • shake can well and spray 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
Questions?

1-866-360-3266

Active Ingredient

Tolnaftate 1%

Other Information

store between 20° to 25°C (68° to 77°F)

Inactive Ingredients

butylated hydroxytoluene, hydroxypropyl cellulose, isobutane,kaolin, magnesium stearate, PPG-12-buteth-16, SD alcohol 40-B (9% w/w), zea mays (corn) starch

When Using This Product
  • avoid contact with the eyes
  • use only as directed. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal.
  • contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120°F.
Stop Use and Ask A Doctor If
  • irritation occurs
  • there is no improvement within 4 weeks

Structured Label Content

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 42229-5 (42229-5)

Drug Facts

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 51945-4 (51945-4)

TOUGH ACTIN' ®



Tinactin ®

tolnaftate ANTIFUNGAL

Cures and prevents

most athlete's foot

Relieves

  • itching
  • burning

POWDER SPRAY

goes on dry

talc free

NET WT 133g (4.6 oz)

Purpose

Antifungal

Warnings

For external use only

Flammable: Do not use near heat, flame, or while smoking

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

Directions
  • wash affected area and dry thoroughly
  • shake can well and spray 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
Questions?

1-866-360-3266

Active Ingredient (Active ingredient)

Tolnaftate 1%

Other Information (Other information)

store between 20° to 25°C (68° to 77°F)

Inactive Ingredients (Inactive ingredients)

butylated hydroxytoluene, hydroxypropyl cellulose, isobutane,kaolin, magnesium stearate, PPG-12-buteth-16, SD alcohol 40-B (9% w/w), zea mays (corn) starch

When Using This Product (When using this product)
  • avoid contact with the eyes
  • use only as directed. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal.
  • contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120°F.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • irritation occurs
  • there is no improvement within 4 weeks

Advanced Ingredient Data


Raw Label Data

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