ANTIBACTERIAL HAND MOUSSE - benzalkonium chloride liquid 
ORGANICA (UK) LTD

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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Drug Facts

Active ingredient

Benzalkonium Chloride 0.13%

Purpose

Antimicrobial

Uses

For handwashing to decrease bacteria on skin.

Recommended for repeated use.

Warnings

For external use only.

When using this product avoid contact with eyes.

In case of eye contact, flush eyes with water.

Stop use and ask a doctor if irritation or redness develops, or if conditions persists for more than 72 hours.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Pump a small amount of foam into the palm of hand

Rub thoroughly over all surfaces of both hands for 15 seconds

Rinse with potable water.

Inactive ingredients

Water, coco-glucoside, laurtrimonium chloride, cocamidopropylamine oxide.

ANTIBACTERIAL

HAND SOAP

MOUSSE

CLEANS IN SECONDS

KILLS 99.9% of BACTERIA

FREE from ALCOHOL

CHLORINE, FRAGRANCE and DYES

8.45fl oz

(250ml)

container label

ANTIBACTERIAL HAND MOUSSE 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76268-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
COCO GLUCOSIDE (UNII: ICS790225B)  
COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)  
LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76268-002-03250 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/28/2011
Labeler - ORGANICA (UK) LTD (235330151)
Establishment
NameAddressID/FEIBusiness Operations
ORGANICA (UK) LTD235330151manufacture

Revised: 12/2011
Document Id: c0035b50-75c2-46fd-a258-61b36e8eee58
Set id: a1f7f49c-bb1f-4ded-83a0-ec31010d8607
Version: 1
Effective Time: 20111213
 
ORGANICA (UK) LTD