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NDC 00363-0890-16 Hand Sanitizer 567 mg/mL Details

Hand Sanitizer 567 mg/mL

Hand Sanitizer is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Walgreens. The primary component is ALCOHOL.

Product Information

NDC	00363-0890
Product ID	0363-0890_da985544-5cbf-4210-a0db-746014eff3b2
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 Sanitizer
Proprietary Name Suffix	n/a
Non-Proprietary Name	Ethyl Alcohol
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	567
Active Ingredient Units	mg/mL
Substance Name	ALCOHOL
Labeler Name	Walgreens
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 00363-0890-16 (00363089016)

Pricing Information	N/A
NDC Package Code	0363-0890-16
Billing NDC	00363089016
Package	59 mL in 1 BOTTLE, PLASTIC (0363-0890-16)
Marketing Start Date	2019-03-08
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 60fadb9c-daa3-42b6-97b8-eade0125385a Details

Active ingredient

Ethyl alcohol 63%

Purpose

Antiseptic

Uses

to decrease bacteria on the skin that could cause disease
recommended for repeated use

Warnings

For external use only: hands

Flammable. Keep away from heat and flame.

When using this product

keep out of eyes. In case of contact with eyes, flush thoroughly with water
avoid contact with broken skin
do not inhale or ingest

Stop use and ask a doctor if

irritation and 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 thoroughly with product and allow to dry without wiping
for children under 6, use only under adult supervision
not recommended for infants

Other information

do not store above 105⁰F
may discolor some fabrics
harmful to wood finishes and plastics

Inactive ingredients

water, glycerin, tocopheryl acetate, acrylates/C10-30 alkyl acrylate crosspolymer, benzophenone-4, fragrance, ext.violet 2, blue 1, red 40

SPL UNCLASSIFIED SECTION

*Effective at eliminating 99.99% of many common harmful germs and bacteria in as little as 15 seconds.

Questions or comments? 1-800-925-4733

Distributed by Walgreen Co.

200 Wilmot Road, Deerfield, IL 60015

100% satisfaction guaranteed

Made in USA with US and foreign components

principal display panel

Walgreens

Hand Sanitizer

Coastal Breeze Scent

Kills 99.99% of germs

2 FL OZ (59 mL)

INGREDIENTS AND APPEARANCE

HAND SANITIZER

ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-0890
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	567 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
SULISOBENZONE (UNII: 1W6L629B4K)
EXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0363-0890-06	33 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/08/2019
2	NDC:0363-0890-16	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/08/2019
3	NDC:0363-0890-34	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/08/2019
4	NDC:0363-0890-38	296 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/08/2019
5	NDC:0363-0890-32	355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/08/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	03/08/2019

Labeler - Walgreens (008965063)

Registrant - Vi-Jon, LLC (088520668)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(0363-0890)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(0363-0890)

Revised: 6/2022

Document Id: da985544-5cbf-4210-a0db-746014eff3b2

Set id: 60fadb9c-daa3-42b6-97b8-eade0125385a

Version: 10

Effective Time: 20220613