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NDC 00363-0898-16 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 Walgreen. The primary component is ALCOHOL.

Product Information

NDC	00363-0898
Product ID	0363-0898_afcb1c69-5580-4cf8-b31d-1d859f9e6c58
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	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 00363-0898-16 (00363089816)

Pricing Information	N/A
NDC Package Code	0363-0898-16
Billing NDC	00363089816
Package	59 mL in 1 BOTTLE, DISPENSING (0363-0898-16)
Marketing Start Date	2016-04-04
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 6a61abf8-77e4-42e5-bd58-c046fe227633 Details

Active ingredient

Ethyl alcohol 63%

Purpose

Antiseptic

Use

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, retinyl palmitate, acrylates/C10-30 alkyl acrylate crosspolymer, benzophenone-4, mannitol, cellulose, hydroxypropyl methylcellulose, fragrance, yellow 5, blue 1, red 4, ultramarines

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 RD., DEERFIELD, IL60015

100% satisfaction guaranteed

walgreens.com

principal display panel

Well at Walgreens

NEW

Hand Sanitizer Guava fruit

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:0363-0898
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)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
SULISOBENZONE (UNII: 1W6L629B4K)
MANNITOL (UNII: 3OWL53L36A)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
HYPROMELLOSES (UNII: 3NXW29V3WO)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
ULTRAMARINE BLUE (UNII: I39WR998BI)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0363-0898-16	59 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	04/04/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	04/04/2016

Labeler - Walgreen (008965063)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(0363-0898)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(0363-0898)

Revised: 3/2022

Document Id: afcb1c69-5580-4cf8-b31d-1d859f9e6c58

Set id: 6a61abf8-77e4-42e5-bd58-c046fe227633

Version: 9

Effective Time: 20220307