amekina Instant Foam Hand Sanitizer 6867 Drug Facts and Label

amekina Instant Foaming Hand Sanitizer by

Drug Labeling and Warnings

amekina Instant Foaming Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Angelini Pharma Inc., ABC Compounding Co., Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

AMEKINA INSTANT FOAMING HAND SANITIZER- alcohol liquid 
Angelini Pharma Inc.

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amekina Instant Foam Hand Sanitizer 6867 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

 apply to hands and rub lightly until dry without wiping or rinsing

Drug Facts Box OTC-Inactive Ingredient Section

water, PEG-10 acrylate, perfluorohexylethyl acrylate copolymer, propylene glycol

amekina Instant Foam Hand Sanitizer 1000mL bag

AMEKINA INSTANT FOAMING HAND SANITIZER 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43595-867
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PEG-10 ACRYLATE/PERFLUOROHEXYLETHYL ACRYLATE COPOLYMER (UNII: D76Z87928N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43595-867-12	1000 mL in 1 BAG; Type 0: Not a Combination Product	11/03/2022	01/29/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M004	11/03/2022	01/29/2025

Labeler - Angelini Pharma Inc. (078843940)

Registrant - ABC Compounding Co., Inc. (003284353)

Establishment
Name	Address	ID/FEI	Business Operations
ABC Compounding Co., Inc.		003284353	manufacture(43595-867)

Revised: 1/2025

Document Id: 2cde6aaa-2aab-3e49-e063-6294a90aed64

34390-5

Set id: ec9310bb-a24e-7e06-e053-2a95a90a6070

Version: 2

Effective Time: 20250129