ALOEGUARD - 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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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

672918P6318.jpg   AloeGuard 18ozimage of bottle label

ALOEGUARD 
chloroxylenol soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63843-729
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL0.005 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
DIGLYCOL STEARATE (UNII: 94YQ11Y95F)  
TROLAMINE LAURYL SULFATE (UNII: E8458C1KAA)  
UREA (UNII: 8W8T17847W)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
D&C GREEN NO. 8 (UNII: I2W85YOX9L)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63843-729-061 in 1 BOX
1800 mL in 1 BAG
2NDC:63843-729-17532 mL in 1 BOTTLE, PLASTIC
3NDC:63843-729-143785 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33307/31/2009
Labeler - HealthLink (807714126)
Registrant - ABC Compounding Co., Inc. (003284353)
Establishment
NameAddressID/FEIBusiness Operations
ABC Compounding Co., Inc.003284353manufacture

Revised: 3/2010
Document Id: 744d492e-5d36-49cc-9037-adbf89c081f2
Set id: 5a1ca264-83ea-446b-be6d-03f69ed84285
Version: 1
Effective Time: 20100322
 
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