Ongo - Fin Liquid
FDA Label NDC 58593-800

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Efficient Laboratories Inc. for the product Ongo - Fin (NDC 58593-800). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, warnings, otc - keep out of reach of children, dosage & administration, indications & usage, inactive ingredient, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredients:

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

Otc - Purpose

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.

Warnings

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.

Otc - Keep Out Of Reach Of Children

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.

Dosage & 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).

Indications & 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.

Inactive Ingredient

Inactive Ingredients:

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


Otc - Questions

Distributed By:

Effecient laboratories, Inc.
Miami FL 33166

www.efficientlab.com

(305) 805-3456  Monday to Friday 

9:00am - 5:00pm EST

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