ANTISEPTIC HAND GEL WITH ALOE - alcohol gel 
PSS World Medical, 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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Antiseptic Hand Gel with Aloe 6711 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

kills 99.9% of most common bacteria in 15 seconds

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

do not use on deep or puncture wounds, consult your doctor

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 Blue 9

Antiseptic Hand Gel with Aloe 6711 18oz

671118P6318.jpg Antiseptic Hand Gel with Aloe 18ozimage of bottle label

ANTISEPTIC HAND GEL WITH ALOE 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68345-711
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL620 mg  in 1 g
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:68345-711-17510 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33307/31/2009
Labeler - PSS World Medical, Inc. (101822682)
Registrant - ABC Compounding Co., Inc. (003284353)
Establishment
NameAddressID/FEIBusiness Operations
ABC Compounding Co., Inc.003284353manufacture

Revised: 2/2010
Document Id: 7c00d669-dee7-4d20-8ff3-7b25d39610db
Set id: 75403ac5-aba9-4820-86e5-a5c839b3ee8a
Version: 1
Effective Time: 20100225
 
PSS World Medical, Inc.