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
- 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 September 11, 2020
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- Download DRUG LABEL INFO: PDF XML
- 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 not final part333E 07/19/2017 Labeler - Betco Corporation, Ltd. (024492831) Registrant - Betco Corporation, Ltd. (024492831) Establishment Name Address ID/FEI Business Operations Betco Corporation, Ltd. 024492831 manufacture(65601-709) , pack(65601-709) , label(65601-709)
