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, Vi-Jon, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Ethyl alcohol 70%

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 or redness develops
• 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 thoroghly 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

water, glyceryl caprylate/caprate, glycerin, isopropyl myristate, tocopheryl acetate, acrylates/C10-30 alkyl acrylate crosspolymer, fragrance, benzophenone-4

SPL UNCLASSIFIED SECTION

*This product is not manufactured or distributed by GOJO Industries, Inc. distributor of Purell Refreshing Gel Advanced Hand Sanitizer.

DISTRIBUTED BY: DZA Brands, LLC, Salsbury, NC 28147/Scarbourough, ME 04074

For prodcut questions or concerns, contact us at 1-866-322-2439.  Please include UPC number and code from package.

Patent pending

Principal Display Panel

Healthy accents

Hand sanitizer

Advanced

More effective formula

COMPARE TO PURELL*

8 FL OZ (236 mL)

370.000/370AB

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55316-370
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
GLYCERYL CAPRYLATE/CAPRATE (UNII: G7515SW10N)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)
SULISOBENZONE (UNII: 1W6L629B4K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55316-370-16	59 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/30/2014
2	NDC: 55316-370-34	236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/30/2014
3	NDC: 55316-370-45	946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/30/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/30/2014

Labeler - DZA Brands (090322194)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		088520668	manufacture(55316-370)