ETHYL ALCOHOL- alcohol cloth

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

Ethyl Alcohol 75%

Dostupné s:

ASP Global, LLc

Podání:

TOPICAL

Druh předpisu:

OTC DRUG

Terapeutické indikace:

Antiseptic for preparation of the skin prior to an injection.

Stav Autorizace:

OTC monograph not final

Charakteristika produktu

ETHYL ALCOHOL- ALCOHOL CLOTH
ASP GLOBAL, LLC
_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._
----------
ETHYL ALCOHOL
_DRUG FACTS_
ACTIVE INGREDIENTS
Ethyl Alcohol 75%
PURPOSE
Antiseptic
USE
for preparation of the skin prior to an injection.
WARNINGS
For external use only. Flammable, keep away from fire or flame. Do not
use with
electrocautery procedures or near eyes. Stop use and ask a doctor if
irritation or
redness develops.
Keep out of reach of children. If swallowed, get medical help or
contact a Poison Control
Center immediately.
DIRECTIONS
Apply topically as needed to clean intended area. Discard after single
use.
INACTIVE INGREDIENTS
Purified Water, Benzethonium Chloride, IPBC
PRINCIPAL DISPLAY PANEL - 80 WIPE APPLICATOR PACKAGE
ASP
MEDICAL
80 WIPES
REORDER #
WHS080
WHS080
www.aspglobal.com
HAND SANITIZER
WIPES
Unscented • 75% Alcohol
Single Use
Not Made With
Natural Rubber Latex
OPEN
ETHYL ALCOHOL
alcohol cloth
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:59448-009
ASP Global, LLc
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
ALCOHOL
75 mL in 100 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
BENZETHONIUM CHLORIDE (UNII: PH41D05744)
WATER (UNII: 059QF0KO0R)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
PACKAGING
#
ITEM
CODE
PACKAGE DESCRIPTION
MARKETING
START DATE
MARKETING
END DATE
1
NDC:59448-
009-01
80 in 1 PACKAGE
11/18/2021
1
5.2 mL in 1 APPLICATOR; Type 2: Prefilled Drug Delivery
Device/System (syringe, patch, etc.)
MARKETING INFORMATION
MARKETING CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
OTC MONOGRAPH NOT
FINAL
part333E
11/18/2021
LABELER -
ASP Global, LLc (080361159)
Revised: 11/2021