INSTANT HAND SANITIZER ALOE VERA- ethyl alcohol gel

Instant Hand Sanitizer Aloe Vera by

Drug Labeling and Warnings

Instant Hand Sanitizer Aloe Vera by is a Otc medication manufactured, distributed, or labeled by Rejoice International, Inc., China Ningbo Shangge Cosmetic Technology Corp.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

PURPOSE

XtraCare Instant Hand Sanitizer Aloe Vera

kills 99.9% of germs

with Moisturizers & Aloe Vera

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

• for handwashing to decrease bacteria on the skin
• recommended for repeated use

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
• supervise children under 6 years in the use of this product

INACTIVE INGREDIENT

water, carbomer, triethanolamine, glycerin, propylene glycol, fragrance, titanium dioxide, aloe barbadensis leaf juice.

OTHER SAFETY INFORMATION

• store at 20oC to 25oC (68o to 77oF)
• may discolor certain fabrics

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

INSTANT HAND SANITIZER ALOE VERA 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57337-012
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	146 mL  in 236 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER HOMOPOLYMER TYPE B (UNII: HHT01ZNK31)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57337-012-01	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/03/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	07/03/2013

Labeler - Rejoice International, Inc. (078741245)

Establishment
Name	Address	ID/FEI	Business Operations
China Ningbo Shangge Cosmetic Technology Corp.		529287434	manufacture(57337-012)