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Name:Aloeguard
Manufacturer:Healthlink
Category:Over-the-counter (OTC) Marketed Drugs


AloeGuard 6729 Drug Facts and Label

ALOEGUARD  - chloroxylenol soap 
HealthLink

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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AloeGuard 6729 Drug Facts and Label

Drug Facts Box OTC-Active Ingredient Section

Chloroxylenol 0.5% w/w

Drug Facts Box OTC-Purpose Section

Antimicrobial

Drug Facts Box OTC-Indications & Usage Section

Specially formulated for the sensitive skin of today's healthcare professional

broad-spectrum antimicrobial hand cleaner

for repeated washings on a daily basis

Drug Facts Box OTC-Warnings Section

For external use only

Drug Facts Box OTC-When Using Section

do not use in or near eyes


Drug Facts Box OTC-Keep Out of Reach of Children Section

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

Drug Facts Box OTC-Dosage & Administration Section

wet hands

apply AloeGuard

wash hands vigorously

rinse thoroughly




Drug Facts Box OTC-General Precautions Section

store at room temperature

Drug Facts Box OTC-Inactive Ingredient Section

Water, TEA lauryl sulfate, Cocamide DEA, Urea, Aloe vera gel, Fragrance, Polyquaternium 7, Glycol Stearate, DMDM hydantoin, Sodium chloride, Methyl paraben, Methylchloroisothiazolinone, Methylisothiazolinone, Tetrasodium EDTA, Propyl paraben, FDC Blue 1, FDC Green 8, FDC Orange 4

AloeGuard 6729 18oz

../images_otc/aloeguard_672918P6318.jpg   AloeGuard 18ozimage of bottle label


ALOEGUARD 
chloroxylenol soap
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63843-729
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLOROXYLENOL (CHLOROXYLENOL) CHLOROXYLENOL 0.005 mL  in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
ALOE VERA LEAF  
METHYLPARABEN  
PROPYLPARABEN  
DIGLYCOL STEARATE  
TROLAMINE LAURYL SULFATE  
UREA  
SODIUM CHLORIDE  
D&C GREEN NO. 8  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63843-729-06 1 BAG ( BAG) in 1 BOX contains a BAG
1 800 mL in 1 BAG This package is contained within the BOX (63843-729-06)
2 NDC:63843-729-17 532 mL in 1 BOTTLE, PLASTIC None
3 NDC:63843-729-14 3785 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 part333 07/31/2009

Labeler - HealthLink (807714126)
Registrant - ABC Compounding Co., Inc. (003284353)
Establishment
Name Address ID/FEI Operations
ABC Compounding Co., Inc. 003284353 manufacture

Revised: 03/2010 HealthLink



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


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