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NDC 49035-0322-21 Ethyl Alcohol 620 mg/mL Details

Ethyl Alcohol 620 mg/mL

Ethyl Alcohol is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Wal-Mart Stores, Inc.. The primary component is ALCOHOL.

Product Information

NDC	49035-0322
Product ID	49035-322_aef853df-6163-495f-9fc1-5a9c79b32582
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	Ethyl Alcohol
Proprietary Name Suffix	n/a
Non-Proprietary Name	Ethyl Alcohol
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	620
Active Ingredient Units	mg/mL
Substance Name	ALCOHOL
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 49035-0322-21 (49035032221)

Pricing Information	N/A
NDC Package Code	49035-322-21
Billing NDC	49035032221
Package	88 mL in 1 BOTTLE, PLASTIC (49035-322-21)
Marketing Start Date	2018-07-05
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 30d057bd-c595-4488-a0ee-cd4b9e6d3cb1 Details

Active ingredient

Ethyl Alcohol 62%

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 fire or 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

Inactive ingredients

water, carbomer, fragrance, glycerin, isopropyl myristate, yellow 6

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY: Wal-Mart Stores, Inc.,

Bentonville, AR 72716

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

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

principal display panel

equate

Sugared Maple Hand Sanitizer

KILLS 99.99% OF GERMS*

Moisturizers leave hands smooth

3 FL OZ (89 mL)

INGREDIENTS AND APPEARANCE

ETHYL ALCOHOL

ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49035-322
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	620 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49035-322-21	88 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/05/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	07/05/2018

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

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(49035-322)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(49035-322)

Revised: 6/2022

Document Id: aef853df-6163-495f-9fc1-5a9c79b32582

Set id: 30d057bd-c595-4488-a0ee-cd4b9e6d3cb1

Version: 11

Effective Time: 20220623