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InstantFOAM non-alcohol hand sanitizer

Dosage form: liquid
Ingredients: BENZALKONIUM CHLORIDE 0.13mL in 100mL
Labeler: Deb USA, Inc.
NDC Code: 11084-057

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

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

INSTANTFOAM NON-ALCOHOL HAND SANITIZER 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11084-057
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE0.13 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
PROPYLENE GLYCOL 
ALOE VERA LEAF 
COCAMIDOPROPYL BETAINE 
LAURAMINE OXIDE 
EDETATE SODIUM 
ANHYDROUS CITRIC ACID 
D&C RED NO. 33 
FD&C BLUE NO. 1 
METHYLCHLOROISOTHIAZOLINONE 
METHYLISOTHIAZOLINONE 
MAGNESIUM NITRATE 
MAGNESIUM CHLORIDE 
Packaging
#Item CodePackage Description
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 AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE0.13 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
PROPYLENE GLYCOL 
ALOE VERA LEAF 
COCAMIDOPROPYL BETAINE 
LAURAMINE OXIDE 
EDETATE SODIUM 
ANHYDROUS CITRIC ACID 
D&C RED NO. 33 
FD&C BLUE NO. 1 
METHYLCHLOROISOTHIAZOLINONE 
METHYLISOTHIAZOLINONE 
MAGNESIUM NITRATE 
MAGNESIUM CHLORIDE 
Packaging
#Item CodePackage Description
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 AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE0.13 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
PROPYLENE GLYCOL 
ALOE VERA LEAF 
COCAMIDOPROPYL BETAINE 
LAURAMINE OXIDE 
EDETATE SODIUM 
ANHYDROUS CITRIC ACID 
D&C RED NO. 33 
FD&C BLUE NO. 1 
METHYLCHLOROISOTHIAZOLINONE 
METHYLISOTHIAZOLINONE 
MAGNESIUM NITRATE 
MAGNESIUM CHLORIDE 
Packaging
#Item CodePackage Description
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 AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE0.13 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
PROPYLENE GLYCOL 
ALOE VERA LEAF 
COCAMIDOPROPYL BETAINE 
LAURAMINE OXIDE 
EDETATE SODIUM 
ANHYDROUS CITRIC ACID 
D&C RED NO. 33 
FD&C BLUE NO. 1 
METHYLCHLOROISOTHIAZOLINONE 
METHYLISOTHIAZOLINONE 
MAGNESIUM NITRATE 
MAGNESIUM CHLORIDE 
Packaging
#Item CodePackage Description
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/FEIOperations
Deb USA, Inc.607378015manufacture

Revised: 09/2010
Document Id: dbb530e5-1e8e-464d-ad20-13ef30d75724
Set id: ec0635ef-6705-4e3d-b4a6-ce184b395282
Version: 2
Effective Time: 20100927
 
Deb USA, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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