XTRACARE FOAM ANTIBACTERIAL HAND WASH WILD BERRY BLAST- benzalkonium chloride soap

XtraCare Foam Antibacterial Hand Wash by

Drug Labeling and Warnings

XtraCare Foam Antibacterial Hand Wash 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

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

PURPOSE

Uses

for hand washing to decrease bacteria on the skin.

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® Foam Antibacterial Hand Wash

Kils 99.9% of bacteria

Compare to Lysol® foam antibacterial hand wash

7.5 Fl Oz (221 mL)

WARNINGS

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.

DOSAGE & ADMINISTRATION

Directions

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

INACTIVE INGREDIENT

Inactive Ingredients

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

OTHER SAFETY INFORMATION

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

XTRACARE FOAM ANTIBACTERIAL HAND WASH  WILD BERRY BLAST
benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57337-048
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.2 g  in 221 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE SODIUM (UNII: MP1J8420LU)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57337-048-01	221 g in 1 BOTTLE; Type 0: Not a Combination Product	01/29/2014

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	Business Operations
China Ningbo Shangge Cosmetic Technology Corp		529287434	manufacture(57337-048)