OTC Medication Information: XtraCare Foam Antibacterial Hand Wash Vanilla Passion Flower

XTRACARE FOAM ANTIBACTERIAL HAND WASH VANILLA PASSION FLOWER- benzalkonium chloride soap
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 Ingredient Purpose

Benzalkonium Chloride 0.1% …………………. Antibacterial

Uses

for hand washing to decrease bacteria on the skin.

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

XtraCare® Foam Antibacterial Hand Wash

Kills 99.9% of bacteria

Compare to Lysol® foam antibacterial hand wash

7.5 Fl Oz (221 mL)

Warnings

for external use only.

When using this product  avoid contact with eyes. In case of eye contact, flush with water,

Stop use and ask a doctor if  irritation and redness develops.

Directions

• pump into hands
• lather vigorously for at least 15 seconds
• rinse hands with water

Inactive Ingredients

water, glycerin, lauramine oxide, PET-150 distearate, cetrimonium chloride, propylene glycol, fragrance, citric acid, tetrasodium EDTA, cocamide MEA, methylchloroisothiazolinone, methylisothiazolinone, D&C red no.33, FD&C blue no.1

Other information : store at room temperature

Questions/Comments?  1-855-345-5575

*this product is not manufactured or distributed by Reckitt Benckiser LLC, the distributor of Lysol® foam antibacterial hand wash.

DISTRIBUTED BY:

REJOICE INTERNATIONAL INC

NORTHVILLE, MI 48168 USA

MADE IN CHINA

XTRACARE FOAM ANTIBACTERIAL HAND WASH VANILLA PASSION FLOWER benzalkonium chloride soap

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57337-047 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 0.2 g in 221 g

Inactive Ingredients Ingredient Name Strength WATER GLYCERIN LAURAMINE OXIDE PEG-150 DISTEARATE CETRIMONIUM CHLORIDE PROPYLENE GLYCOL CITRIC ACID MONOHYDRATE EDETATE SODIUM COCO MONOETHANOLAMIDE METHYLCHLOROISOTHIAZOLINONE METHYLISOTHIAZOLINONE D&C RED NO. 33 FD&C BLUE NO. 1

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:57337-047-01 221 g in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 01/29/2014

Labeler — Rejoice International (078741245)

Establishment
Name	Address	ID/FEI	Operations
China Ningbo Shangge Cosmetic Technology Corp		529287434	manufacture (57337-047)

Revised: 09/2019 Rejoice International