HAND SANITIZER- ethyl alcohol gel

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Sam's West Inc, Vi-Jon, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Ethyl Alcohol 65%

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

skin irritation develops.

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 105⁰ F
• may discolor some fabrics
• harmful to wood finishes and plastics

Inactive ingredients

benzophenone-4, carbomer, fragrance, glycerin, isopropyl myristate, propylene glycol, tocopheryl acetate, water

SPL UNCLASSIFIED SECTION

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

Distributed by SAM'S West, Inc.

608 S.W. 8th Street

Bentonville, AR 72716

This product not packaged for resale

principal display panel 

Member's Mark Quality Guaranteed

Hand Sanitizer

Kills 99.99% of germs*

Plus Moisturizers and Vitamin E

2 FL OZ (59 mL)

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68196-951
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	578 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SULISOBENZONE (UNII: 1W6L629B4K)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
glycerin (UNII: PDC6A3C0OX)
isopropyl myristate (UNII: 0RE8K4LNJS)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68196-951-16	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/08/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/08/2014

Labeler - Sam's West Inc (051957769)

Registrant - Vi-Jon, Inc. (088520668)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon, Inc.		088520668	manufacture(68196-951)