XTRACARE FOAMING HAND SANITIZER- benzalkonium chloride gel

XtraCare Foaming Hand Sanitizer by

Drug Labeling and Warnings

XtraCare Foaming Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by China Ningbo Shangge Cosmetic Technology Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient                                    Purpose

Benzalkonium Chloride 0.13% .......... Antimicrobial

PURPOSE

Use:

to help reduce 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 immediately.

INDICATIONS & USAGE

XtraCare® Foaming Hand Sanitizer

Superior Protection

Alcohol Free

Kills 99.9% of germs

Clean Fresh Scent

7 FL OZ (207 mL)

WARNINGS

Warnings: for external use only.

When using this product  Avoid contact with eyes. In case of eye contact, flush with plenty of water. Avoid contact with broken skin.

Stop use and ask a doctor if skin iffitation develops.

DOSAGE & ADMINISTRATION

Directions

wet hands thoroughly with product and rub into skin until dry.

For children under 6, use only under adult supervision.

Not recommended for infancts.

INACTIVE INGREDIENT

Inactive Ingredients: water, cetrimonium chloride, disodium cocoamphodiacetate, fragrance, glycerin, citric acid, dimethicone, tetrasodium EDTA, methylchloroisothiazolinone, methylisothiazolinone.

OTHER SAFETY INFORMATION

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 FOAMING HAND SANITIZER 
benzalkonium chloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58503-057
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	3 g  in 207 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)
GLYCERIN (UNII: PDC6A3C0OX)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DIMETHICONE (UNII: 92RU3N3Y1O)
EDETATE SODIUM (UNII: MP1J8420LU)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58503-057-01	207 g in 1 PACKAGE; Type 0: Not a Combination Product	02/18/2014

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

Labeler - China Ningbo Shangge Cosmetic Technology Corp (529287434)

Establishment
Name	Address	ID/FEI	Business Operations
China Ningbo Shangge Cosmetic Technology Corp		529287434	manufacture(58503-057)