OTC Medication Information: XtraCare Hand Sanitizer Moisurize with Vitamin E and Aloe

XTRACARE HAND SANITIZER MOISURIZE WITH VITAMIN E AND ALOE- 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.

Active Ingredients 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 99.9% of Germs

Moisturize with Vitamin E & Aloe

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 in the use of this product

Inactive Ingredients

water, carbomer, triethanolamine, glycerin, propylene glycol, fragrance, aloe barbadensis leaf juice, tocopheryl acetate, fd&c blue no. 1, fd&c yellow no.5

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

XTRACARE HAND SANITIZER MOISURIZE WITH VITAMIN E AND ALOE ethyl alcohol gel

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57337-044 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (ALCOHOL) ALCOHOL 146 g in 236 g

Inactive Ingredients Ingredient Name Strength WATER CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) TROLAMINE GLYCERIN PROPYLENE GLYCOL ALOE VERA LEAF .ALPHA.-TOCOPHEROL ACETATE FD&C BLUE NO. 1 FD&C YELLOW NO. 5

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:57337-044-01 236 g in 1 BOTTLE None

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

Labeler — Rejoice International (078741245)

Establishment
Name	Address	ID/FEI	Operations
China Ningbo Shangge Cosmetic Technology Corp		529287434	manufacture (57337-044)

Revised: 09/2019 Rejoice International