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Product NDC Code | 58593-800 | ||||
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Drug Name | Ongo - fin |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | LIQUID | ||||
Application Number | M005 | ||||
Labeler Name | Efficient Laboratories Inc. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients: Tolnaftate 1% v/v........Antifungal
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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).
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Acetone, Aloe Vera Gel, Propylene Glycol, Purified Water and Tocopheryl Acetate (Vitamin E).
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.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.
Purpose
Information about the drug product’s indications for use.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.
Spl product data elements
Usually a list of ingredients in a drug product.Ongo - Fin TOLNAFTATE ACETONE ALOE VERA LEAF PROPYLENE GLYCOL WATER ALPHA-TOCOPHEROL TOLNAFTATE TOLNAFTATE
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.OngoFinLabel
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Distributed By: Effecient laboratories, Inc. Miami FL 33166 www.efficientlab.com (305) 805-3456 Monday to Friday 9:00am - 5:00pm EST
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API