INSTANT HAND SANITIZER- ethyl alcohol gel

Instant Hand Sanitizer by

Drug Labeling and Warnings

Instant Hand Sanitizer 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 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64092-318
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	6 mL  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
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: 64092-318-02	2 in 1 PACKAGE
1	NDC: 64092-318-01	10 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(64092-318)