Label: ANTIBACTERIAL HAND- benzalkonium chloride soap
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Contains inactivated NDC Code(s)
NDC Code(s): 50518-309-11 - Packager: CUSTOM RESEARCH LABS INC
- 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 March 29, 2022
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- ACTIVE INGREDIENT
- PURPOSE
- USES
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
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INACTIVE INGREDIENTS
WATER (AQUA), SODIUM C14-16 OLEFIN SULFONATE, COCAMIDOPROPYL BETAINE, COCAMIDE MIPA, GLYCERIN, PHENOXYETHANOL, POLYSORBATE 20, CITRUS LIMON (LEMON) SEED OIL, D-LIMONENE, SODIUM CHLORIDE, CITRUS AURANTIUM DULCIS (ORANGE) OIL, CITRUS SINENSIS (BLOOD ORANGE) OIL, ETHYLHEXYL GLYCERIN, CITRIC ACID, POLYQUATERNIUM-10.
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INGREDIENTS AND APPEARANCE
ANTIBACTERIAL HAND
benzalkonium chloride soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50518-309 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 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1) GLYCERIN (UNII: PDC6A3C0OX) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYSORBATE 20 (UNII: 7T1F30V5YH) LEMON OIL (UNII: I9GRO824LL) LIMONENE, (+)- (UNII: GFD7C86Q1W) SODIUM CHLORIDE (UNII: 451W47IQ8X) ORANGE OIL (UNII: AKN3KSD11B) CITRUS SINENSIS SEED OIL (UNII: 9WMM6OQ58A) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) POLYQUATERNIUM-10 (1000 MPA.S AT 2%) (UNII: GMR4PEN8PK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50518-309-11 355 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 12/01/2020 Labeler - CUSTOM RESEARCH LABS INC (028611598) Registrant - CUSTOM RESEARCH LABS INC (028611598)