ALOEGUARD ANTIMICROBIAL- chloroxylenol soap 
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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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Active ingredient

Chloroxylenol 0.5% w/w

Purpose

Antimicrobial

Keep out of reach of children

In case of accidental ingestion, seek medical attention or contact a poison control center immediately.

Uses

 Specially formulated for the sensitive skin of today's healthcare professional
 broad-spectrum antimicrobial hand cleaner
 for repeated washings on a daily basis

Warnings

For external use only When using this product  do not use in or near eyes Keep out of reach of children. In case of accidental ingestion, seek medical attention or contact a poison control center immediately.

Directions

 wet hands  apply AloeGuard  wash hands vigorously  rinse thoroughly.

Other information

 store at room temperature

Inactive ingredients:

Water, Sodium Lauryl Sulfate, Cocamide MIPA, Sodium Laureth Sulfate, Aloe Barbadensies Leaf Juice, Fragrance, C9-11 Pareth-6, Proplyene Glycol, Diazoliolinyl Urea, Glycol Stearate, Isopropyl Myristate, Polyquaternium 7, Ammonium Chloride, Methyl Paraben, Propyl Paraben, Tetrasodium EDTA, Methylchloroisothiazolinone (and) Methylisothiazolinone, FD&C Blue #1, FD&C Green #8, D&C Orange #4.

PRINCIPAL DISPLAY PANEL - 3785 mL Bottle Label

AloeGuard
Antimicrobial Soap
Net Contents 1 U.S. Gallon (3.8 Liters)

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ALOEGUARD ANTIMICROBIAL 
chloroxylenol soap
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:63843-509
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLOROXYLENOL (CHLOROXYLENOL) CHLOROXYLENOL5 g  in 1000 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
GLYCOL STEARATE 
COCO MONOISOPROPANOLAMIDE 
SODIUM LAURYL SULFATE 
SODIUM LAURETH SULFATE 
C9-11 PARETH-6 
PROPYLENE GLYCOL 
ISOPROPYL MYRISTATE 
ALOE VERA LEAF 
DIAZOLIDINYL UREA 
METHYLPARABEN 
PROPYLPARABEN 
METHYLCHLOROISOTHIAZOLINONE 
METHYLISOTHIAZOLINONE 
EDETATE SODIUM 
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) 
AMMONIUM CHLORIDE 
Product Characteristics
ColorgreenScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63843-509-11208000 mL in 1 DRUM
2NDC:63843-509-17800 mL in 1 BAG
3NDC:63843-509-18118 mL in 1 BOTTLE, PLASTIC
4NDC:63843-509-25532 mL in 1 BOTTLE, PLASTIC
5NDC:63843-509-283785 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E08/20/2013
Labeler - HealthLink (807714126)

Revised: 8/2013
Document Id: 4790141f-94f1-4ff4-b360-772f6928203d
Set id: 033efdf5-fce9-494d-8cbc-f147b9899d2b
Version: 1
Effective Time: 20130813
 
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