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NDC 69790-0488-08 Antibacterial Hand Wash 1.313 mg/mL Details

Antibacterial Hand Wash 1.313 mg/mL

Antibacterial Hand Wash is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Uline. The primary component is BENZALKONIUM CHLORIDE.

Product Information

NDC	69790-0488
Product ID	69790-488_c0b92930-c293-4c07-99cf-0647bae4e0c0
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 Wash
Proprietary Name Suffix	n/a
Non-Proprietary Name	Benzalkonium chloride 0.13%
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	1.313
Active Ingredient Units	mg/mL
Substance Name	BENZALKONIUM CHLORIDE
Labeler Name	Uline
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333A
Listing Certified Through	2024-12-31

Package

Package Images

NDC 69790-0488-08 (69790048808)

Pricing Information	N/A
NDC Package Code	69790-488-08
Billing NDC	69790048808
Package	3785 mL in 1 BOTTLE, PLASTIC (69790-488-08)
Marketing Start Date	2018-05-27
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 9e7a97a0-f3dd-40cf-b25e-8ebb65693926 Details

Active ingredient

Benzalkonium chloride 0.13%

Purpose

Antibacterial

Use

for handwashing to decrease bacteria on the skin

Warnings

For external use only: hands

When using this product

avoid contact with the eyes. If contact occurs, rinse eyes with water

Stop use and ask a doctor if

irritation or redness develops
condition persists for more than 72 hours

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

wet hands
apply palmful to hands
scrub thoroughly
rinse thoroughly

Inactive ingredients

water, lauramine oxide, cocamidopropyl betaine, lauramidopropylamine oxide, sodium chloride, myristamidopropylamine oxide, glycerin, fragrance, disteareth-75 IPDI, PEG-150 distearate, citric acid, tetrasodium EDTA, benzophenone-4, sodium benzoate, red 33, red 40, yellow 5

SPL UNCLASSIFIED SECTION

Distributed by: ULINE, 12575 Uline Drive

Pleasant Prairie, WI 53158

1-800-295-5510

unline.com

principal display panel

ULINE

HAND SOAP

ANTIBACTERIAL

S-17080

1 GAL (3.78 L)

1-800-295-5510

uline.com

INGREDIENTS AND APPEARANCE

ANTIBACTERIAL HAND WASH

benzalkonium chloride 0.13% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69790-488
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.313 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
water (UNII: 059QF0KO0R)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
myristamidopropylamine oxide (UNII: 3HSF539C9T)
GLYCERIN (UNII: PDC6A3C0OX)
DISTEARETH-75 ISOPHORONE DIISOCYANATE (UNII: 5365FJ30SC)
PEG-150 distearate (UNII: 6F36Q0I0AC)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE SODIUM (UNII: MP1J8420LU)
SULISOBENZONE (UNII: 1W6L629B4K)
SODIUM BENZOATE (UNII: OJ245FE5EU)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69790-488-08	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/27/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	05/27/2018

Labeler - Uline (039612668)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(69790-488)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(69790-488)

Revised: 9/2022

Document Id: c0b92930-c293-4c07-99cf-0647bae4e0c0

Set id: 9e7a97a0-f3dd-40cf-b25e-8ebb65693926

Version: 8

Effective Time: 20220926