amekina Instant Hand Sanitizer Gel 6047 Drug Facts and Label

amekina Instant Hand Sanitizer Gel by

Drug Labeling and Warnings

amekina Instant Hand Sanitizer Gel 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 HAND SANITIZER GEL- alcohol gel 
Angelini Pharma Inc.

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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 Hand Sanitizer Gel.jpg

AMEKINA INSTANT HAND SANITIZER GEL 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43595-122
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)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43595-122-47	473 mL in 1 BOTTLE, PLASTIC; 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(43595-122)

Revised: 1/2025

Document Id: 2cdbc5ab-33bf-b2d0-e063-6294a90af015

34390-5

Set id: ec927c88-05ad-b1d9-e053-2a95a90a7dce

Version: 2

Effective Time: 20250129