XTRACARE FOAMING HAND SANITIZER- benzalkonium chloride gel 
China Ningbo Shangge Cosmetic Technology Corp

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 Foaming Hand Sanitizer

Active Ingredient                                    Purpose

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

Use:

to help reduce bacteria on the skin

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

XtraCare® Foaming Hand Sanitizer

Superior Protection

Alcohol Free

Kills 99.9% of germs

Clean Fresh Scent

7 FL OZ (207 mL)

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.

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

Questions/Comments? 1-855-345-5575

DISTRIBUTED BY:

REJOICE INTERNATIONAL INC

NORTHVILLE, MI 48168 USA

MADE IN CHINA

label image

XTRACARE FOAMING HAND SANITIZER 
benzalkonium chloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58503-057
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE3 g  in 207 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58503-057-01207 g in 1 PACKAGE; Type 0: Not a Combination Product02/18/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E02/18/2014
Labeler - China Ningbo Shangge Cosmetic Technology Corp (529287434)
Establishment
NameAddressID/FEIBusiness Operations
China Ningbo Shangge Cosmetic Technology Corp529287434manufacture(58503-057)

Revised: 9/2019
Document Id: 927035cb-87e2-d33c-e053-2a95a90a39b4
Set id: 81d7c2ff-48ff-4bc5-bf48-5558c3b742ac
Version: 2
Effective Time: 20190913
 
China Ningbo Shangge Cosmetic Technology Corp