Label: BARIELLE PROFESSIONAL MAXIMUM STRENGTH FUNGUS RX ANTIFUNGAL PRO- tolnaftate solution
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Contains inactivated NDC Code(s)
NDC Code(s): 42593-001-30 - Packager: Fisk Industries
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated February 2, 2012
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- Official Label (Printer Friendly)
- Active ingredient
- Uses
- Warnings
- Keep out of reach of children
- Stop use
- Do not use
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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
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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
- Description
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- Inner Package 1
- Inner Package 2
- Outer Package 1
- Outer Package 2
- Outer Package 3
- Outer Package 4
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INGREDIENTS AND APPEARANCE
BARIELLE PROFESSIONAL MAXIMUM STRENGTH FUNGUS RX ANTIFUNGAL PRO
tolnaftate solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42593-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE 1.0 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETETH-20 (UNII: I835H2IHHX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) OCTOXYNOL 9 (UNII: 7JPC6Y25QS) ALOE VERA LEAF (UNII: ZY81Z83H0X) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) IMIDUREA (UNII: M629807ATL) CETYL ALCOHOL (UNII: 936JST6JCN) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) TROLAMINE (UNII: 9O3K93S3TK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42593-001-30 1 in 1 PACKAGE 1 30 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 01/01/2012 Labeler - Fisk Industries (067633180) Establishment Name Address ID/FEI Business Operations Private Label Partners, Inc. 046033481 manufacture