Land: Vereinigte Staaten
Sprache: Englisch
Quelle: NLM (National Library of Medicine)
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
Angelini Pharma Inc.
TOPICAL
OTC DRUG
Antiseptic for hand-washing to decrease bacteria on the skin, only when water is not available irritation and redness develop
OTC monograph not final
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 Lesen Sie das vollständige Dokument