HAND SANITIZER- alcohol gel

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by DZA Brands LLC, Vi-Jon. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Ethyl Alcohol 65%

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 the eyes, flush thoroughly with water.
• avoid contact with broken skin
• do not inhale or ingest
• avoid contact with broken skin

Stop use and ask a doctor if

 skin irritation develops

Stop use and ask a doctor if

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

Inactive ingredients

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

ADVERSE REACTIONS

Not manufactured or distributed by Johnson and Johnson, the owner and distributor of Purell Hand Sanitizer

Made in USA with US and foreign components.

Distributed by: DZA Brands LLC

2110 Executive Drive, Salisbury, NC 28147

1-866-322-2439

951.000/951AA-AB

principal display panel

healty accents

hand sanitizer

waterless

compare to purell

8 FL OZ (236 mL)

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55316-951
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	.65 kg  in 100 L

Inactive Ingredients
Ingredient Name	Strength
SULISOBENZONE (UNII: 1W6L629B4K)
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
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: 55316-951-16	.199 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/20/2011
2	NDC: 55316-951-34	1.005 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/20/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/20/2011

Labeler - DZA Brands LLC (090322194)

Registrant - Vi-Jon (088520668)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		088520668	manufacture(55316-951)