ADVANCED HAND SANITIZER- ethyl alcohol gel

Advanced Hand Sanitizer by

Drug Labeling and Warnings

Advanced Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Onpoint, Inc., Vi-Jon. 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

• skin irritation 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 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

water, aloe barbadensis leaf juice, glyceryl caprylate/caprate, glycerin, isopropyl myristate, tocopheryl acetate, acrylates/C10-30 alkyl acrylate crosspolymer, fragrance, benzophenone-4, blue 1, yellow 5

SPL UNCLASSIFIED SECTION

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

DISTRIBUTED BY ONPOINT, INC
2 PARAGON DRIVE, MONTVALE, NJ 07645

PRINCIPAL DISPLAY PANEL

Live Better

Advanced Hand Sanitizer

WITH ALOE

More Effective Formula

• KILLS MORE THAN 99.99% OF GERMS*

8 FL OZ (236 mL)

439.000/439AB

INGREDIENTS AND APPEARANCE

ADVANCED HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51143-439
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	700 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
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)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51143-439-16	59 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	09/30/2014
2	NDC: 51143-439-34	236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	09/30/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/30/2014

Labeler - Onpoint, Inc. (001367366)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		088520668	manufacture(51143-439)