CAREN HAND SANITIZER ANTISEPTIC- benzalkonium chloride gel 
Caren Products, LLC

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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Active Ingredient(s)

Benzalkonium Chloride....................Purpose: Antimicrobial and First Aid Antiseptic

Purpose

Antimicrobial and First Aid Antiseptic

Uses

Warnings

For external use only.

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

Discontinue use if irratation or redness develops.  If condition persists for more than 72 hours consult a doctor.

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

Directions

Inactive ingredients

Aloe, Carbomer, Ethylhexylglycerin, Glycerin, Phenoxyethanol, Purified Water

2oz label

4oz label

32oz label

12oz label

24oz label

CAREN HAND SANITIZER ANTISEPTIC 
benzalkonium chloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77009-0420
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.0013 kg  in 1 kg
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
ALOE (UNII: V5VD430YW9)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77009-0420-10.059 kg in 1 TUBE; Type 0: Not a Combination Product05/28/2020
2NDC:77009-0420-20.118 kg in 1 TUBE; Type 0: Not a Combination Product05/28/2020
3NDC:77009-0420-30.948 kg in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/28/2020
4NDC:77009-0420-40.354882 kg in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/24/2020
5NDC:77009-0420-50.709765 kg in 1 POUCH; Type 0: Not a Combination Product09/24/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/28/2020
Labeler - Caren Products, LLC (932901676)
Establishment
NameAddressID/FEIBusiness Operations
Cosco International, Inc.016433141manufacture(77009-0420)

Revised: 9/2020
Document Id: d9d2ad5a-c74b-4a16-8d47-f5a9a755720f
Set id: 43aa4fe7-1f1a-444b-ab4c-8f807ed5c18c
Version: 2
Effective Time: 20200924
 
Caren Products, LLC