AMEKINA INSTANT FOAMING HAND SANITIZER- alcohol liquid

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

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Herunterladen Fachinformation (SPC)
03-11-2022

Wirkstoff:

ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)

Verfügbar ab:

Angelini Pharma Inc.

Verabreichungsweg:

TOPICAL

Verschreibungstyp:

OTC DRUG

Anwendungsgebiete:

Antiseptic for hand-washing to decrease bacteria on the skin, only when water is not available irritation and redness develop

Berechtigungsstatus:

OTC monograph not final

Fachinformation

                                AMEKINA INSTANT FOAMING HAND SANITIZER- ALCOHOL LIQUID
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._
----------
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
Angelini Pharma Inc.
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
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMB
                                
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