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NDC 49035-0628-96 Hand Wash 1.3 mg/mL Details

Hand Wash 1.3 mg/mL

Hand Wash is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Wal-Mart Stores, Inc.. The primary component is BENZALKONIUM CHLORIDE.

Product Information

NDC	49035-0628
Product ID	49035-628_c87f4160-b0ab-479c-bd2d-d24a68e82004
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	Hand Wash
Proprietary Name Suffix	n/a
Non-Proprietary Name	Benzalkonium chloride
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	1.3
Active Ingredient Units	mg/mL
Substance Name	BENZALKONIUM CHLORIDE
Labeler Name	Wal-Mart Stores, Inc.
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 49035-0628-96 (49035062896)

Pricing Information	N/A
NDC Package Code	49035-628-96
Billing NDC	49035062896
Package	222 mL in 1 BOTTLE, PUMP (49035-628-96)
Marketing Start Date	2016-09-14
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 0f2cde1f-2ee5-4bfa-8c53-8e645f5d2e4b Details

Active ingredient

Benzalkonium chloride 0.13%

purpose

Antibacterial

Use

for handwashing to decrease bacteria on the skin

warnings

For external use only: hands only

When using this product

avoid contact with eyes. If contact occurs, rinse eyes thoroughly 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 to hands
scrub thoroughly
rinse thoroughly

Inactive ingredients

water, cocamidopropyl betaine, lauramidopropylamine oxide, lauramine oxide, myristamidopropylamine oxide, glycerin, fragrance, citric acid, tetrasodium EDTA, benzophenone-4, sodium benzoate, blue 1, red 33

Questions or comments?

1-888-287-1915

SPL UNCLASSIFIED SECTION

Satisfaction guaranteed - For questions or comments please call 1-888-287-1915

DISTRIBUTED BY: Wal-Mart Stores, Inc.

Bentonville, AR 72716

Empty Before Recycling

PLASTIC BOTTLE

principal display panel

equate

Fresh Scent

FOAMING

HAND WASH

ANTIBACTERIAL

Helps kill harmful germs
Gentle and mild formula

PARABEN

TRICLOSAN

PHTHALATE FREE

Made in the USA with domastic and imported ingredients

Factory Certified

7.5 FL OZ (221 mL)

INGREDIENTS AND APPEARANCE

HAND WASH

benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49035-628
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
MYRISTAMIDOPROPYLAMINE OXIDE (UNII: 3HSF539C9T)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
GLYCERIN (UNII: PDC6A3C0OX)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE SODIUM (UNII: MP1J8420LU)
sulisobenzone (UNII: 1W6L629B4K)
SODIUM BENZOATE (UNII: OJ245FE5EU)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:49035-628-45	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/14/2016
2	NDC:49035-628-96	222 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	09/14/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	09/14/2016

Labeler - Wal-Mart Stores, Inc. (051957769)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(49035-628)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(49035-628)

Revised: 2/2022

Document Id: c87f4160-b0ab-479c-bd2d-d24a68e82004

Set id: 0f2cde1f-2ee5-4bfa-8c53-8e645f5d2e4b

Version: 10

Effective Time: 20220222