FREE HAND- alcohol gel 
Atco International

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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Free Hand 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, DMDM hydantoin, tocopheryl acetate, aloe barbadensis

Free Hand 6605 18oz

product label

Free Hand 18oz

FREE HAND 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62712-221
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)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
DIISOPROPYLAMINE (UNII: BR9JLI40NO)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62712-221-17532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/01/2009
2NDC:62712-221-24118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/01/2009
3NDC:62712-221-28149 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/01/2009
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E10/01/2009
Labeler - Atco International (033504929)
Registrant - ABC Compounding Co., Inc. (003284353)
Establishment
NameAddressID/FEIBusiness Operations
ABC Compounding Co., Inc.003284353manufacture(62712-221)

Revised: 12/2018
Document Id: e0c76648-ee60-4b0f-a39f-0fd472b993c1
Set id: a03d1e0c-3bd1-4f6e-af37-c649a20b225f
Version: 4
Effective Time: 20181228
 
Atco International