Label: WINNING HANDS FOAMING ANTIBACTERIAL- benzalkonium chloride soap
- NDC Code(s): 65601-754-04, 65601-754-54, 65601-754-55
- Packager: Betco Corporation, Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 14, 2019
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- Winning Hands Foaming Antibacterial
- Winning Hands Foaming Antibacterial
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Winning Hands Foaming Antibacterial
Warnings
- For external use only.
- Avoid contact with eyes.
- Children under the age of 6 should be supervised by an adult when using this product.
- Discontinue use is irritation or redness develops.
- If irritation persists for more than 72 hours, consult a physician.
- KEEP OUT OF REACH OF CHILDREN.
- If swallowed, get medical help or contact a Poison Control Center right away.
- Winning Hands Foaming Antibacterial
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Winning Hands Foaming Antibacterial
Inactive Ingredients
Water, Potassium Cocoate, Propylene Glycol, Glycerin, Tetrasodium EDTA, Fragrance, Bronopol, Sodium Citrate,
Magnesium Nitrate, Sodium Hydroxyacetate, Ethanol, Aloe Barbadensis Leaf Juice, Trisodium Nitriloacetate,
FD&C Yellow #5, Sodium Hydroxide, Methylchloroisothiazolinone, Magnesium Chloride, Methylisothiazolinone,
FD&C Red #40. - Winning Hands Foaming Antibacterial
- Winning Hands Foaming Antibacterial
- Winning Hands Foaming Antibacterial
- Winning Hands Foaming Antibacterial
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INGREDIENTS AND APPEARANCE
WINNING HANDS FOAMING ANTIBACTERIAL
benzalkonium chloride soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65601-754 Route of Administration Topical Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 13 mg in 1.0 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) POTASSIUM COCOATE (UNII: F8U72V8ZXP) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) GLYCERIN (UNII: PDC6A3C0OX) DITETRACYCLINE TETRASODIUM EDETATE (UNII: WX0A0IT7K5) BRONOPOL (UNII: 6PU1E16C9W) SODIUM CITRATE (UNII: 1Q73Q2JULR) MAGNESIUM NITRATE (UNII: 77CBG3UN78) SODIUM GLYCOLATE (UNII: B75E535IMI) ALCOHOL (UNII: 3K9958V90M) ALOE (UNII: V5VD430YW9) TRISODIUM NITRILOTRIACETATE (UNII: E3C8R2M0XD) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) SODIUM HYDROXIDE (UNII: 55X04QC32I) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) FD&C RED NO. 40 (UNII: WZB9127XOA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65601-754-54 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/12/2012 2 NDC:65601-754-55 208000 mL in 1 DRUM; Type 0: Not a Combination Product 11/12/2012 3 NDC:65601-754-04 3780 mL in 1 JUG; Type 0: Not a Combination Product 11/12/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 11/12/2012 Labeler - Betco Corporation, Ltd. (024492831) Registrant - Betco corporation, Ltd. (024492831) Establishment Name Address ID/FEI Business Operations Betco Corpo, Ltd. 024492831 manufacture(65601-754) , pack(65601-754) , label(65601-754)
