HAND SANITIZER- benzalkonium chloride lotion 
Humphreyline

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.

----------

Drug Facts

benzalkonium chloride (0.13%)

antimicrobial

Hand sanitizer to help reduce bacteria on the skin

For external use only

Do not use in or near the eyes

Stop use and ask a doctor if irritation or rash appears and lasts

Keep out of reach of children. If swallowed contact a doctor or Poison Control Center right away

Wet hands thoroughly with product and allow to dry without wiping

Keep out of reach of children. If swallowed contact a doctor or Poison Control Center right away.

Water, cetearyl alcohol, petrolatum, behenamidopropyl dimethylamine lactate, lauryl laurate, glycerin, glycereth-2-cocoate, dimethicone, benzoic acid

frontpanel

HAND SANITIZER 
benzalkonium chloride lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:19392-500
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 g  in 1000 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
PETROLATUM (UNII: 4T6H12BN9U)  
BEHENAMIDOPROPYL DIMETHYLAMINE BEHENATE (UNII: 96T33VV28E)  
LAURYL LAURATE (UNII: GPW77G0937)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERETH-2 COCOATE (UNII: JWM00VS7HC)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:19392-500-0215 g in 1 BOTTLE, PLASTIC
2NDC:19392-500-0330 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E01/01/2014
Labeler - Humphreyline (122539042)
Establishment
NameAddressID/FEIBusiness Operations
Humphreyline122539042pack(19392-500)

Revised: 12/2013
Document Id: b4b8dc11-a87f-46d2-924c-cb7cbeec608a
Set id: d1045e66-e281-4127-a584-61949034b73c
Version: 2
Effective Time: 20131203
 
Humphreyline