INSTANT HAND SANITIZER- alcohol gel

Instant Hand sanitizer by

Drug Labeling and Warnings

Instant Hand sanitizer by is a Otc medication manufactured, distributed, or labeled by WakeFern Food Corporation, Vi-Jon. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient
Ethyl Alcohol 65%

Purpose
Antiseptic

INDICATIONS & USAGE

Uses to decrease bacteria on the skin that could cause disease  recommended for repeated use

WARNINGS

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.
do not inhale or ingest
avoid contact with broken skin

Stop use and ask a doctor if skin irritation develops

Keep out of reach of children.  In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately

DOSAGE & ADMINISTRATION

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

STORAGE AND HANDLING

Other information do not store above 105⁰F  may discolor some fabrics  harmful to wood finishes and plastics

INACTIVE INGREDIENT

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

GENERAL PRECAUTIONS

Effective at eliminating over 99.99% of many common harmful germs and bacteria in as little as 15 seconds.
Made in USA with US and foreign components.
SDA-MO-15036 SDA-WI-2059 SDA WI-2486 DSP-MO-28 DSP-MO-34

ADVERSE REACTIONS

We welcome your questions and comments.
Call: 1-800-ShopRite (8am-8pm EST) E-mail: www.shoprite.com
Write: Wakefern Food Corp. Consumer Affairs -P7-103
600 York St. Elizabeth, NJ 07207
Please provide product UPC and code stamped on product.
DISTRIBUTED BY
WAKEFERN FOOD CORPORATION
5000 RIVERSIDE DRIVE
KEASBEY, NJ 08832

PRINCIPAL DISPLAY PANEL

ShopRite
INSTANT
Hand
Sanitizer
with Moisturizers
+ Vitamin E
Kills 99.99% of Germs
without Water
32 FL OZ (946 mL)

INGREDIENTS AND APPEARANCE

INSTANT HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41190-951
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
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41190-951-16	.059 L in 1 BOTTLE, PLASTIC
2	NDC: 41190-951-34	.236 L in 1 BOTTLE, PUMP
3	NDC: 41190-951-45	.946 L in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/29/2011

Labeler - WakeFern Food Corporation (069722418)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture