INSTANTFOAM NON-ALCOHOL HAND SANITIZER - benzalkonium chloride liquid 
SAFE-T-FRESH ALCOHOL FREE HAND SANITIZER - benzalkonium chloride liquid 
DRUMMOND AERO INSTANT - benzalkonium chloride liquid 
UNITED LABS INSTANT FOAM - benzalkonium chloride liquid 
Deb USA, Inc.

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

Antibacterial

Uses

For hand sanitizing to reduce bacteria on the skin

Warnings

For external use only

When using this product avoid contact with eyes.

In case of eye contact, flush with water.

Keep out of reach of children.

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

Directions

Apply one shot to dry hands, rub into skin

No rinsing required

Inactive ingredients

Water, Propylene Glycol, Aloe Barbadensis Leaf Juice, Cocamidopropyl Betaine, Lauramine Oxide, Tetrasodium EDTA, Fragrance, Citric Acid, Magnesium Nitrate, Methylchloroisothiazolinone, Magnesium Chloride, Methylisothiazolinone, Blue 1 (CI 42090), Red 33 (CI 17200)

deb

InstantFOAM

non-alcohol hand sanitizer

refreshing

no water required

use anywhere, any time

use everyday

Kills 99.99% of common germs

deb foam technology

56827-01-116

1 Liter - 33.8 Fluid Ounces

container label

INSTANTFOAM NON-ALCOHOL HAND SANITIZER 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11084-057
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)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
EDETATE SODIUM (UNII: MP1J8420LU)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
MAGNESIUM NITRATE (UNII: 77CBG3UN78)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11084-057-0147 mL in 1 BOTTLE, PUMP
2NDC:11084-057-053780 mL in 1 BOTTLE, PLASTIC
3NDC:11084-057-202000 mL in 1 BOTTLE, PLASTIC
4NDC:11084-057-271000 mL in 1 BOTTLE, PLASTIC
5NDC:11084-057-40400 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/01/2010
SAFE-T-FRESH ALCOHOL FREE HAND SANITIZER 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11084-129
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)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
EDETATE SODIUM (UNII: MP1J8420LU)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
MAGNESIUM NITRATE (UNII: 77CBG3UN78)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11084-129-271000 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/01/2010
DRUMMOND AERO INSTANT 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11084-112
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)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
EDETATE SODIUM (UNII: MP1J8420LU)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
MAGNESIUM NITRATE (UNII: 77CBG3UN78)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11084-112-0147 mL in 1 BOTTLE, PUMP
2NDC:11084-112-271000 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/01/2010
UNITED LABS INSTANT FOAM 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11084-113
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)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
EDETATE SODIUM (UNII: MP1J8420LU)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
MAGNESIUM NITRATE (UNII: 77CBG3UN78)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11084-113-27400 mL in 1 BOTTLE, PUMP
2NDC:11084-113-4047 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/01/2010
Labeler - Deb USA, Inc. (607378015)
Establishment
NameAddressID/FEIBusiness Operations
Deb USA, Inc.607378015manufacture

Revised: 9/2010
Document Id: dbb530e5-1e8e-464d-ad20-13ef30d75724
Set id: ec0635ef-6705-4e3d-b4a6-ce184b395282
Version: 2
Effective Time: 20100927
 
Deb USA, Inc.