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


Drug Facts

AERO FLORAFREE 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

Active ingredient

Chloroxylenol, 0.5%

Purpose

Antibacterial

Uses

For hand washing to decrease bacteria on skin

Warnings

For external use only

Avoid contact with eyes

Consult with a physician if ingested

Keep out of the reach of children

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, Propylene Glycol, TEA-Lauryl Sulfate, PPG-24-Glycereth-24, Sodium Laureth Sulfate, Aloe Barbadensis Leaf Juice, Cocamidopropyl Betaine, Allantoin, Fragrance, Tetrasodium EDTA, Diazolidinyl Urea, Citric Acid, Methylparaben, Propylparaben, Methylchloroisothiazolinone, Methylisothiazolinone.

Aero Florafree

Antibacterial Foaming Soap with 0.5% PCMX

Reduces risk of cross infection and provides a rapid broad-spectrum reduction of pathogenic microorganisms

deb foam technology

Proudly made in the USA by Deb SBS, Inc.

27260-01-112

2 Liter

67.6 Fluid Ounces

Rev. 9-08

container label


AERO FLORAFREE ANTIBACTERIAL  
chloroxylenol liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:11084-130
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
chloroxylenol (phenol) chloroxylenol 0.5 mL  in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
PROPYLENE GLYCOL  
TROLAMINE LAURYL SULFATE  
SODIUM LAURETH SULFATE  
ALOE VERA LEAF  
COCAMIDOPROPYL BETAINE  
ALLANTOIN  
EDETATE SODIUM  
DIAZOLIDINYL UREA  
CITRIC ACID MONOHYDRATE  
METHYLPARABEN  
MAGNESIUM NITRATE  
PROPYLPARABEN  
METHYLCHLOROISOTHIAZOLINONE  
MAGNESIUM CHLORIDE  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:11084-130-20 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 part333A 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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