HOME FORMATION ANTIBACTERIA -BERRY- benzalkonium chloride liquid 
PATCOS COSMETICS (INDIA) PRIVATE LIMITED

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

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

Warnings

For external use only.
When using this product avoid contact with eyes. In case of eyes contact, flush with water.

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

Keep out of reach of children if swallowed, get medical help or contact a Poison control center right away.

Uses

For hand washing to decrease bacteria on the skin.

Directions

• Pump into hands
• Lather vigorously for at least 15 seconds
• Rinse and dry thoroughly

Inactive ingredient

Water, Sodium Laureth Sulphate, Sodium Laureth sulfate & Glycol Distearate & Cocamide MEA & Laureth - 10, Cocamido Propyl Betaine,
Cocomonoethanolamide, Sodium Chloride, Glycerine, Perfume, PEG 150 Distearate, Bronopol, Disodium EDTA, Phenoxyethanol, Benzophenone 3, Citric Acid, FD & C Red 40, CI. No 16035.

Label

image description

HOME FORMATION ANTIBACTERIA -BERRY 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68121-007
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
COCO MONOETHANOLAMIDE (UNII: C80684146D)  
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
BRONOPOL (UNII: 6PU1E16C9W)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
BENZOPHENONE (UNII: 701M4TTV9O)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
WATER (UNII: 059QF0KO0R)  
GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
LAURETH-10 (UNII: BD7AST04GA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68121-007-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product01/29/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/29/2021
Labeler - PATCOS COSMETICS (INDIA) PRIVATE LIMITED (916169451)
Establishment
NameAddressID/FEIBusiness Operations
PATCOS COSMETICS (INDIA) PRIVATE LIMITED675973979manufacture(68121-007)

Revised: 2/2021
Document Id: bafdd1f9-153a-3868-e053-2995a90afc91
Set id: 621b2e99-9363-42b7-8487-fabf2449ac54
Version: 1
Effective Time: 20210210
 
PATCOS COSMETICS (INDIA) PRIVATE LIMITED