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NDC 00363-0651-96 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 Walgreen. The primary component is BENZALKONIUM CHLORIDE.

Product Information

NDC	00363-0651
Product ID	0363-0651_dfafde61-3865-4434-a530-667846e9c2ec
Associated GPIs	46990002410100
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	Walgreen
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 00363-0651-96 (00363065196)

Pricing Information	N/A
NDC Package Code	0363-0651-96
Billing NDC	00363065196
Package	221 mL in 1 BOTTLE, PLASTIC (0363-0651-96)
Marketing Start Date	2020-01-05
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 14578125-7935-4f1d-865a-213bcacc7d2a 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 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, red 4, yellow 6

Questions?

1-800-925-4733

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY:

WALGREEN CO.

200 WILMOT RD.

DEERFIELD, IL 60015

2018 WALGREEN CO

MADE IN U.S.A. WITH U.S. AND FOREIGN COMPONENTS

ORG0918-F REV-1019

principal display panel

CITRUS

ANTIBACTERIAL

FOAMING

HAND SOAP

GENTLE & MILD

FORMULA

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:0363-0651
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)
GLYCERIN (UNII: PDC6A3C0OX)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE SODIUM (UNII: MP1J8420LU)
sulisobenzone (UNII: 1W6L629B4K)
SODIUM BENZOATE (UNII: OJ245FE5EU)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0363-0651-96	221 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/05/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	01/05/2020

Labeler - Walgreen (008965063)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(0363-0651)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(0363-0651)

Revised: 4/2022

Document Id: dfafde61-3865-4434-a530-667846e9c2ec

Set id: 14578125-7935-4f1d-865a-213bcacc7d2a

Version: 7

Effective Time: 20220412