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NDC 50518-0309-11 ANTIBACTERIAL HAND 0.13 g/100mL Details

ANTIBACTERIAL HAND 0.13 g/100mL

ANTIBACTERIAL HAND is a TOPICAL SOAP in the HUMAN OTC DRUG category. It is labeled and distributed by CUSTOM RESEARCH LABS INC. The primary component is BENZALKONIUM CHLORIDE.

Product Information

NDC	50518-0309
Product ID	50518-309_db64e907-3919-7025-e053-2995a90a8684
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	ANTIBACTERIAL HAND
Proprietary Name Suffix	n/a
Non-Proprietary Name	BENZALKONIUM CHLORIDE
Product Type	HUMAN OTC DRUG
Dosage Form	SOAP
Route	TOPICAL
Active Ingredient Strength	0.13
Active Ingredient Units	g/100mL
Substance Name	BENZALKONIUM CHLORIDE
Labeler Name	CUSTOM RESEARCH LABS INC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333A
Listing Certified Through	2023-12-31

Package

Package Images

NDC 50518-0309-11 (50518030911)

Pricing Information	N/A
NDC Package Code	50518-309-11
Billing NDC	50518030911
Package	355 mL in 1 BOTTLE (50518-309-11)
Marketing Start Date	2020-12-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL eca1f9e7-c8c6-42d2-9240-5130aaf2d52b Details

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.

SPL UNCLASSIFIED SECTION

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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)

Revised: 3/2022

Document Id: db64e907-3919-7025-e053-2995a90a8684

Set id: eca1f9e7-c8c6-42d2-9240-5130aaf2d52b

Version: 5

Effective Time: 20220329