ANTIBACTERIAL HAND- benzalkonium chloride soap
CUSTOM RESEARCH LABS INC

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.

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CRL (as CMO) - ANTIBACTERIAL HAND SOAP (50518-309)

ACTIVE INGREDIENT

BENZALKONIUM CHLORIDE 0.13%

PURPOSE

ANTISEPTIC

USES

HELPS ELIMINATE BACTERIA ON HANDS

WARNINGS

FOR EXTERNAL USE ONLY.

WHEN USING THIS PRODUCT, AVOID CONTACT WITH EYES. IN CASE OF CONTACT, FLUSH WITH WATER.

KEEP OUT OF REACH OF CHILDREN EXCEPT UNDER ADULT SUPERVISION. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS

WASH HANDS AND RINSE.

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.

01b LBL_Antibacterial Hand Soap_12oz

ANTIBACTERIAL HAND
benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50518-309
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50518-309-11	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	12/01/2020

Labeler - CUSTOM RESEARCH LABS INC (028611598)

Registrant - CUSTOM RESEARCH LABS INC (028611598)