FDA Label for Toenail Fungus Treatment
View Indications, Usage & Precautions
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- OTC - DO NOT USE
- OTC - WHEN USING
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Toenail Fungus Treatment Product Label
The following document was submitted to the FDA by the labeler of this product 100 Karma Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
25% Undecylenic Acid
Otc - Purpose
Antifungal
Indications & Usage
- Helps inhibit the growth of fungus.
- Improves the appearance of nails affected by fungus, including discoloration, thickening, splitting, crumbing, and brittleness.
Warnings
For external use only
Otc - Do Not Use
Do not use
- on children under 2 years of age unless directed by a doctor
- on diaper rash
Otc - When Using
avoid contact with eyes. Do not exceed the recommended daily dosage unless directed by a doctor.
Otc - Stop Use
Stop and ask a doctor if ▪ irritation occurs. ▪ there is no improvement within 4 weeks.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of accidental ingestion, seek medical advice immediately or contact a Poison Control Center right away.
Dosage & Administration
▪ Wash affected area and dry thoroughly.
▪ Apply a thin layer of the product over the affected area (around the nails and underneath nail tips) twice daily or directed by a doctor.
▪ Supervise children in the use of this product.
Other Safety Information
store at 20-25°C (68-77°F)
Inactive Ingredient
Isopropyl Myristate, Tea Tree Oil
Otc - Questions
Email: [email protected]
Package Label.Principal Display Panel
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