GBG ALOEGEL - alcohol gel 
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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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GBG AloeGel 6727 Drug Facts and Label

Drug Facts Box OTC-Active Ingredient Section

Ethyl Alcohol 62%

Drug Facts Box OTC-Purpose Section

Antimicrobial

Drug Facts Box OTC-Indications & Usage Section

to sanitize hands without requiring water or a rinse

Drug Facts Box OTC-Warnings Section

FLAMMABLE

For external use only

Drug Facts Box OTC-When Using Section

do not use near heat or open flame

do not use in or near eyes

discontinue use if irritation and redness develop

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

apply gel liberally to unsoiled hands and rub in thoroughly

allow to dry without wiping or rinsing

Drug Facts Box OTC-General Precautions Section

store at room temperature

Drug Facts Box OTC-Inactive Ingredient Section

Water, Aloe Vera Gel, Carbomer, Diisopropylamine,
Glycerin, Isopropyl Myristate, Fragrance, Phenoxyethanol, Tocopheryl Acetate, Acid Green 1

GBG AloeGel 6727 4oz

6727Z4P6318.jpg GBG AloeGel 4 ozimage of bottle label

GBG ALOEGEL 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63843-727
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CARBOMER 934 (UNII: Z135WT9208)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
NONOXYNOL-9 (UNII: 48Q180SH9T)  
DIISOPROPYLAMINE (UNII: BR9JLI40NO)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63843-727-061 in 1 BOX
1800 mL in 1 BAG
2NDC:63843-727-17532 mL in 1 BOTTLE, PLASTIC
3NDC:63843-727-24115 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: 2/2010
Document Id: 65f6c1af-3b18-4163-9c0d-981ee4854ea8
Set id: 9ab14727-06b2-4fa0-a650-e34e3908ff51
Version: 1
Effective Time: 20100225
 
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