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NDC 49035-0444-68 Hand wash 1.3 mg/mL Details

Hand wash 1.3 mg/mL

Hand wash is a TOPICAL SOAP 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	49035-0444
Product ID	49035-444_25269c5f-95f3-46f6-9901-ad3c4f08959a
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	SOAP
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 49035-0444-68 (49035044468)

Pricing Information	N/A
NDC Package Code	49035-444-68
Billing NDC	49035044468
Package	332 mL in 1 BOTTLE, PUMP (49035-444-68)
Marketing Start Date	2018-06-19
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL c3cdbce7-f9b9-4708-bbb8-f8fec1012e0d 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 with water.

Stop use and ask a doctor if

irritation or redness develop
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, blue 1, red 33

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY Wal-Mart Stores, Inc.

Bentonville, AR 72716

Satisfaction guaranteed - or we'll replace it or give you your money back. For questions or comments or to report an undersired reaction or side effect, please call 1-888-287-1915.

Made in the USA with 90% or more US materials. Factory certified.

how2recycle.com Plastic Bottle

principal display panel

Equate Spring Rain Liquid Hand Soap

Antibacterial

Helps kill harmful germs
Helps smooth and soften skin
Great for the entire family

Paraben and triclosan free

56 FL OZ (1.65 L)

INGREDIENTS AND APPEARANCE

HAND WASH

benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49035-444
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)
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)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49035-444-68	332 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/19/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	06/19/2018

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

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(49035-444)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(49035-444)

Revised: 2/2022

Document Id: 25269c5f-95f3-46f6-9901-ad3c4f08959a

Set id: c3cdbce7-f9b9-4708-bbb8-f8fec1012e0d

Version: 12

Effective Time: 20220225