XTRACARE HAND SANITIZER MOISTURIZE WITH VITAMIN E- ethyl alcohol gel
Rejoice International

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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XtraCare Hand Sanitizer

Active Ingredient Purpose

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

Uses

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

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

XtraCare® Hand Sanitizer Antibacterial

Kills 99% of Germs

Moisturize with Vitamin E

8 Fl Oz (236 mL)

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.

Directions

wet hands thoroughly with product
briskly rub hands together until dry
supervise children under 6 years of age in the use of this product

Inactive Ingredients:

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

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

label image

XTRACARE HAND SANITIZER MOISTURIZE WITH VITAMIN E
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:57337-043
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
TROLAMINE (UNII: 9O3K93S3TK)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:57337-043-01	236 g in 1 BOTTLE; Type 0: Not a Combination Product	01/24/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	01/24/2014

Labeler - Rejoice International (078741245)

Name	Address	ID/FEI	Business Operations
Establishment
China Ningbo Shangge Cosmetic Technology Corp		529287434	manufacture(57337-043)

Revised: 9/2019

Document Id: 9270c1c6-9325-7fdc-e053-2995a90a1547

Set id: 13c99570-0859-4310-843a-5eb266698eb3

Version: 2

Effective Time: 20190913

Rejoice International