INSTANT HAND SANITIZER - ORIGINAL- ethyl alcohol gel

Instant Hand Sanitizer - Original by

Drug Labeling and Warnings

Instant Hand Sanitizer - Original by is a Otc medication manufactured, distributed, or labeled by Great Lakes Wholesale & Marketing, LLC, China Ningbo Shangge Cosmetic Technology Corp.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient                              Purpose

Ethyl Alcohol 62.0%......................Antimicrobial

PURPOSE

XtraCare Instant Hand Sanitizer - Original

Kills 99.9% of Germs with Moisturizers & Vitamin E

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

USE: 

• hand sanitizer to help reduce bacteria on the skin that may cause disease

WARNINGS

Warnings:

for external use only.

Flammable. Keep away from heat and flame.

Do not use in the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.

DOSAGE & ADMINISTRATION

Directions:

• wet hands thoroughly with product
• briskly rub hands together until dry
• children under 6 years of age should be supervised by an adult when using.

INACTIVE INGREDIENT

Inactive ingredients:

carbomer, glycerin, propylene glycol, tocopheryl acetate (vitamin E), triethanolamine, water, fragrance.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

INSTANT HAND SANITIZER - ORIGINAL 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64092-317
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	33 mL  in 53 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER TYPE B (UNII: HHT01ZNK31)
TROLAMINE (UNII: 9O3K93S3TK)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64092-317-02	2 in 1 PACKAGE
1	NDC: 64092-317-01	53 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	07/05/2013

Labeler - Great Lakes Wholesale & Marketing, LLC (361925498)

Establishment
Name	Address	ID/FEI	Business Operations
China Ningbo Shangge Cosmetic Technology Corp.		529287434	manufacture(64092-317)