HAND-E XL- alcohol gel 
ABC Compounding Co., 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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Hand-E XL 6605 Drug Facts and Label

Drug Facts Box OTC-Active Ingredient Section

Ethyl Alcohol 62%

Drug Facts Box OTC-Purpose Section

Antiseptic

Drug Facts Box OTC-Indications & Usage Section

for hand-washing to decrease bacteria on the skin, only when water is not available

Drug Facts Box OTC-Warnings Section

FLAMMABLE, keep away from fire and flames

For external use only

Drug Facts Box OTC-When Using Section

do not get into eyes

if contact occurs, rinse eyes thoroughly with water

Drug Facts Box OTC-Stop Use Section

irritation and redness develop

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

if swallowed, get medical help or contact a Poison Control Center right away

Drug Facts Box OTC-Dosage & Administration Section

wet hands thoroughly with product and allow to dry without wiping

Drug Facts Box OTC-Inactive Ingredient Section

water, diisopropylamine, carbomer, propylene glycol, tocopheryl acetate, aloe barbadensis

Hand-E XL 6605 Drug Facts and Label

product label

Hand-E XL 16 oz Label

HAND-E XL 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62257-606
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)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
DIISOPROPYLAMINE (UNII: BR9JLI40NO)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62257-606-17532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/01/2005
2NDC:62257-606-24118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/01/2005
3NDC:62257-606-28149 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/01/2005
4NDC:62257-606-30473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/01/2005
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E04/01/2005
Labeler - ABC Compounding Co., Inc. (003284353)
Registrant - ABC Compounding Co., Inc. (003284353)
Establishment
NameAddressID/FEIBusiness Operations
ABC Compounding Co., Inc.003284353manufacture(62257-606)

Revised: 12/2018
Document Id: 239c502b-0bd7-4121-891f-0ce8c11e0b2c
Set id: ea0dd205-5f3d-40d6-9a75-b1b292e591a6
Version: 4
Effective Time: 20181231
 
ABC Compounding Co., Inc.