Label: ANTIBACTERIAL FOAMING SKIN CLEANSER- benzalkonium chloride soap
- NDC Code(s): 65601-709-04, 65601-709-29, 65601-709-55
- Packager: Betco Corporation, Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated July 3, 2024
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
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WARNINGS
Warnings
- For external use only.
- Avoid contact with eyes.
- If contact occurs, rinse thoroughly with water.
- 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.
- DOSAGE & ADMINISTRATION
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INACTIVE INGREDIENT
Inactive Ingredients
Water, Potasium 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.
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ANTIBACTERIAL FOAMING SKIN CLEANSER
benzalkonium chloride soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65601-709 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.13 mg in 1 mL Inactive Ingredients Ingredient Name Strength GERANIOL (UNII: L837108USY) 2-TERT-BUTYLCYCLOHEXYLOXYBUTANOL (UNII: 1DR20642YH) DIHYDROMYRCENOL (UNII: 46L1B02ND9) TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) ALLYL HEPTANOATE (UNII: AU4CYG9V68) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) MAGNESIUM NITRATE (UNII: 77CBG3UN78) ALCOHOL (UNII: 3K9958V90M) ALOE VERA LEAF (UNII: ZY81Z83H0X) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) FD&C RED NO. 40 (UNII: WZB9127XOA) COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK) LINALOOL, (+/-)- (UNII: D81QY6I88E) 2-TERT-BUTYLCYCLOHEXYL ACETATE (UNII: 364FV60913) CITRAL (UNII: T7EU0O9VPP) N-ALKYL DIMETHYL BENZYL AMMONIUM CHLORIDE (C12-C18) (UNII: 9U1Q4T4ZYS) HYDROGEN PEROXIDE (UNII: BBX060AN9V) LIMONENE, (+)- (UNII: GFD7C86Q1W) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65601-709-29 1000 mL in 1 BAG; Type 0: Not a Combination Product 07/19/2017 2 NDC:65601-709-55 208000 mL in 1 DRUM; Type 0: Not a Combination Product 07/19/2017 3 NDC:65601-709-04 3780 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/19/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug 505G(a)(3) 07/19/2017 Labeler - Betco Corporation, Ltd. (005050158) Registrant - Betco Corporation, Ltd. (005050158) Establishment Name Address ID/FEI Business Operations Betco Corporation, Ltd. 005050158 manufacture(65601-709) , label(65601-709)
