Barielle Fungus Rx Maximum Strength Anti-Fungal

Dosage form: solution
Ingredients: TOLNAFTATE 1.0mL in 100mL
Labeler: Fisk Industries
NDC Code: 42593-002

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Barielle Fungus Rx Maximum Strength Anti-Fungal Solution

Active ingredient

Active ingredient                                   Purpose
Tolnaftate 1.0%.................................Antifungal

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

BARIELLE FUNGUS RX MAXIMUM STRENTH ANTI-FUNGAL SOLUTION  30 ml / Fl. Oz. (U.S.) e

Directions

Inner Package 1

Inner Package 2

BARIELLE FUNGUS RX MAXIMUM STRENGTH ANTI-FUNGAL 
tolnaftate solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42593-002
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (TOLNAFTATE) TOLNAFTATE1.0 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
POLYETHYLENE GLYCOL 400 
CETOSTEARYL ALCOHOL 
CETETH-20 
PROPYLENE GLYCOL 
COCAMIDOPROPYL BETAINE 
OCTOXYNOL 9 
ALOE VERA LEAF 
GLYCERYL MONOSTEARATE 
STEARYL ALCOHOL 
IMIDUREA 
CETYL ALCOHOL 
METHYLPARABEN 
PROPYLPARABEN 
TROLAMINE 
Packaging
#Item CodePackage Description
1NDC:42593-002-301 BOTTLE (BOTTLE) in 1 PACKAGE
130 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C01/01/2012
Labeler - Fisk Industries (067633180)
Establishment
NameAddressID/FEIOperations
Private Label Partners, Inc.046033481manufacture

Revised: 02/2012
 
Fisk Industries

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web2)