Drud Facts

Drud Facts
SPL v8
SPL
SPL Set ID bb5fb71f-bee0-42fa-9c9f-6231b555324c
Route
TOPICAL
Published
Effective Date 2020-02-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (1 mg)
Inactive Ingredients
Aloe Vera Leaf Propylene Glycol Water Alpha-tocopherol Acetone

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2004-02-01 Until 2018-03-29

Description

Active Ingredients: Tolnaftate 1% v/v........Antifungal


Medication Information

Warnings and Precautions

Warnings:

Do not use on children under 2 years of age. Do not use for diaper rash. For external use only. Do not use if safety seal is broken or missing.

Indications and Usage

When using this product, avoid contact with eyes. Stop use and consult a doctor if irritation occurs or if there is no improvement within 4 weeks.

Dosage and Administration

Directions:

  • Clean the affected area with soap and water, dry thoroughly.
  • Apply a thin layer of Ongo Fin over the affected area twice daily (morning and night) or as directed by a physician.
  • 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 more effective results, continue applying Ongo Fin for 2 more weeks after the symptoms have disappeared.
  • Supervise children in the use if this product.
  • Ongo Fin is not effective on scalp or nails
  • Store between 15 - 30 degrees celcius ( 59 - 86 degrees farhenheit).

Description

Active Ingredients: Tolnaftate 1% v/v........Antifungal

Section 50565-1

Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Flammable. Keep away from fire and flame.

Section 51727-6

Inactive Ingredients:

Acetone, Aloe Vera Gel, Propylene Glycol, Purified Water and Tocopheryl Acetate (Vitamin E).



Section 51945-4

Section 53413-1

Distributed By:

Effecient laboratories, Inc.

Miami FL 33166

www.efficientlab.com

(305) 805-3456  Monday to Friday 

9:00am - 5:00pm EST

Section 55105-1

Uses:

For effective treatment of Athlete's Foot (tinea pedis). For the relieve if itching, burning feet.

Treatment for ringworm (tinea corporis). For the prevention of athlete's foot with daily use.

Section 55106-9

Active Ingredients:

Tolnaftate 1% v/v........Antifungal


Structured Label Content

Indications and Usage (34067-9)

When using this product, avoid contact with eyes. Stop use and consult a doctor if irritation occurs or if there is no improvement within 4 weeks.

Dosage and Administration (34068-7)

Directions:

  • Clean the affected area with soap and water, dry thoroughly.
  • Apply a thin layer of Ongo Fin over the affected area twice daily (morning and night) or as directed by a physician.
  • 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 more effective results, continue applying Ongo Fin for 2 more weeks after the symptoms have disappeared.
  • Supervise children in the use if this product.
  • Ongo Fin is not effective on scalp or nails
  • Store between 15 - 30 degrees celcius ( 59 - 86 degrees farhenheit).

Warnings and Precautions (34071-1)

Warnings:

Do not use on children under 2 years of age. Do not use for diaper rash. For external use only. Do not use if safety seal is broken or missing.

Section 50565-1 (50565-1)

Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Flammable. Keep away from fire and flame.

Section 51727-6 (51727-6)

Inactive Ingredients:

Acetone, Aloe Vera Gel, Propylene Glycol, Purified Water and Tocopheryl Acetate (Vitamin E).



Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Distributed By:

Effecient laboratories, Inc.

Miami FL 33166

www.efficientlab.com

(305) 805-3456  Monday to Friday 

9:00am - 5:00pm EST

Section 55105-1 (55105-1)

Uses:

For effective treatment of Athlete's Foot (tinea pedis). For the relieve if itching, burning feet.

Treatment for ringworm (tinea corporis). For the prevention of athlete's foot with daily use.

Section 55106-9 (55106-9)

Active Ingredients:

Tolnaftate 1% v/v........Antifungal


Advanced Ingredient Data


Raw Label Data

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