Active Ingredient
Active ingredient Purpose
Tolnaftate 1.0%.................................Antifungal
Barielle Fungus Rx Maximum Strength Anti-fungal
FDA Label NDC 42593-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Fisk Industries for the product Barielle Fungus Rx Maximum Strength Anti-fungal (NDC 42593-002). 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 active ingredient, uses, warnings, keep out of reach of children, stop use, do not use, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
- Cures and prevents most athlete's foot (tinea pedis). - Effectively relieves itching, burning, cracking and scaling accompanying the above condition.
Warnings
For external use only
Keep Out Of Reach Of Children
- In case of accidental ingestion contact a physician, emergency medical care facility or poison control center.
Stop Use
- Stop use and ask a physician if rash or irritation occurs.
Do Not Use
On children under 2 unless directed by a doctor.
Directions
- To prevent athlete's foot, wash the feet and dry thoroughly. - Apply a thin layer of the product to the feet once or twice daily ( morning and/or night ). - Supervise children in the use of this product. - Pay special attention to spaces between the toes - Wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.
Other Information
- You may report a serious adverse event from use of this product to Fisk Industries, Inc. 50 Ramland Road, Orangeburg, NY 10962
Inactive Ingredients
Water, PEG-8, Cetearyl Alcohol, Ceteth-20 Phosphate, Decetyl Phosphate, Propylene Glycol, Cocamidopropyl Betaine, Octoxynol-9, Aloe Barbadensis Leaf Extract, Glyceryl Stearate, Hydroxyethyl Cellulose, Stearyl Alcohol, Imidazolidinyl Urea, Cetyl Alcohol, Methylparaben, Propylparaben, Triethanolamine.
Purpose
Antifungal
Description
BIORIUS sprl, 2 rue René Descartes B-7000 Mons, Belgium DISTRIBUTED BY FISK INDUSTRIES ORANGEBURG, NY 10962, USA
Package Label.Principal Display Panel
BARIELLE FUNGUS RX MAXIMUM STRENTH ANTI-FUNGAL SOLUTION 30 ml / Fl. Oz. (U.S.) e
Directions
Inner Package 1
Inner Package 1 (Innerpackage1)
Inner Package 2
Inner Package 2 (Innerpackage2)
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