XTRACARE INSTANT HAND SANITIZER- ethyl alcohol liquid

XtraCare Instant Hand Sanitizer by

Drug Labeling and Warnings

XtraCare Instant Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Rejoice International, 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

Uses

for handwashing to decrease bacteria on the skin

recommended for repeated use

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

XtraCare® Instant Hand Sanitizer

Kills 99.9% Of Germs

Moisturizes with Vitamin E

2 FL OZ (60 mL)

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

INACTIVE INGREDIENT

Inactive Ingredients

water, carbomer, triethanolamine, glycerin, propylene glycol, fragrance, tocopheryl acetate.

OTHER SAFETY INFORMATION

Other Information

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

Questions/Comments? 1-855-345-5575

DISTRIBUTED BY

REJOICE INTERNATIONAL INC

NORTHVILLE, MI 48168 USA

MADE IN CHINA

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

XTRACARE INSTANT HAND SANITIZER 
ethyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57337-058
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	37 g  in 60 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
TROLAMINE (UNII: 9O3K93S3TK)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57337-058-02	2 in 1 PACKAGE	02/18/2014
1	NDC: 57337-058-01	60 g in 1 PACKAGE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	02/18/2014

Labeler - Rejoice International (078741245)

Establishment
Name	Address	ID/FEI	Business Operations
China Ningbo Shangge Cosmetic Technology Corp		529287434	manufacture(57337-058)