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Name:Aero Cleanse2 Antibacterial
Manufacturer:Deb Usa, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


Drug Facts

AERO CLEANSE2 ANTIBACTERIAL  - chloroxylenol 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

Chloroxylenol, 2.1%

Purpose

Antibacterial

Uses

For hand washing 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 foaming cleanser to dry hands

Rub hands together to spread lather

Wash for 15-20 seconds

Rinse and dry hands thoroughly

Inactive ingredients

Water, Ammonium Lauryl Sulfate, Hexylene Glycol, Glycerin, Acrylates/Steareth-20 Methacrylate Copolymer, Sodium Hydroxide.

Aero CleansE-2

Antibacterial Cleanser

A high-quality formula designed for highest level of hygiene.

Rinses easily from the skin with no soapy residue.

deb foam technology

Proudly made in the U.S.A. by Deb

cser@debsbs.com

www.debgroup.com

27270-01-112

2 Liter

67.6 Fluid Ounces

Rev. 08-10

container label


AERO CLEANSE2 ANTIBACTERIAL 
chloroxylenol liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:11084-071
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLOROXYLENOL (PHENOL) CHLOROXYLENOL 2.1 mL  in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
AMMONIUM LAURYL SULFATE  
HEXYLENE GLYCOL  
GLYCERIN  
STEARETH-20  
SODIUM HYDROXIDE  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:11084-071-20 2000 mL in 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 01/01/2010

Labeler - Deb USA, Inc. (607378015)
Establishment
Name Address ID/FEI Operations
Deb USA, Inc. 607378015 manufacture

Revised: 02/2011 Deb USA, Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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