AMEKINA INSTANT HAND SANITIZER GEL- alcohol gel 
Angelini Pharma 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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amekina Instant Hand Sanitizer Gel 6047 Drug Facts and Label

Drug Facts Box OTC-Active Ingredient Section

Ethyl Alcohol 70% v/v

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, DMDM hydantoin,  diidopropylamine, carbomer, propylene glycol, tocopheryl acetate, aloe barbadensis, 

amekina Instant Hand Sanitizer Gel 6047 Drug Facts and Label

Amekina Instant Label Image Hand Sanitizer Gel.jpg

AMEKINA INSTANT HAND SANITIZER GEL 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43595-122
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)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
DIISOPROPYLAMINE (UNII: BR9JLI40NO)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43595-122-8989 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/03/2022
2NDC:43595-122-47473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/03/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E11/03/2022
Labeler - Angelini Pharma Inc. (078843940)
Registrant - ABC Compounding Co., Inc. (003284353)
Establishment
NameAddressID/FEIBusiness Operations
ABC Compounding Co., Inc.003284353manufacture(43595-122)

Revised: 11/2022
Document Id: ec927771-a5ed-372e-e053-2995a90ad7ea
Set id: ec927c88-05ad-b1d9-e053-2a95a90a7dce
Version: 1
Effective Time: 20221103
 
Angelini Pharma Inc.