ANTIBACTERIAL HAND SANITIZER- alcohol gel

Antibacterial Hand Sanitizer by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredient

Ethyl alcohol 70%

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 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

Claims

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

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

Principal display panel

fred's Pharmacy

ADVANCED

Hand Sanitizer

Fresh Feeling Gel

Kills more than 99.99% of germs

Moisturizing formula with Vitamin E

Compare to Purell Advanced Hand Sanitizer

2 FL OZ (59 mL)

INGREDIENTS AND APPEARANCE

ANTIBACTERIAL HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55315-370
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 INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
SULISOBENZONE (UNII: 1W6L629B4K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55315-370-16	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/02/2015
2	NDC: 55315-370-34	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/02/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	02/02/2015

Labeler - Fred's, Inc (005866116)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		088520668	manufacture(55315-370)