MEDLINE- ethyl alcohol liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Medline Industries, LP

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antiseptic - health care personnel hand rub to help reduce bacteria that potentially can cause disease

Authorization status:

OTC monograph not final

Summary of Product characteristics

MEDLINE- ETHYL ALCOHOL LIQUID
MEDLINE INDUSTRIES, LP
_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._
----------
022 MEDLINE 80% ANTISEPTIC HAND RUB
_ACTIVE INGREDIENT_
Alcohol 80% v/v
_PURPOSE_
Antiseptic
_USES_
health care personnel hand rub to help reduce bacteria that
potentially can cause
disease
_WARNINGS_
FOR EXTERNAL USE ONLY. FLAMMABLE. KEEP AWAY FROM HEAT OR FLAME.
DO NOT USE
in children less than 2 months of age
on open skin wounds
WHEN USING THIS PRODUCT
keep out of eyes, ears, and mouh. In case of contact with eyes, rinse
eyes
thoroughly with water.
STOP USE AND ASK A DOCTOR
if irritation or rash occurs. These may be signs of a serious
condition.
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control Center
right away.
_DIRECTIONS_
Place enough product on hands to cover all surfaces. Rub hands
together until dry.
Supervise children under 6 years of age when using this product to
avoid swallowing.
_OTHER INFORMATION_
store between 15-30ºC (59-86ºF)
avoid freezing and excessive heat above 40ºC (104ºF)
_INACTIVE INGREDIENTS_
glycerin, hydrogen peroxide, purified water USP
MANUFACTURING INFORMATION
Manufactured for: Medline Industries, Inc.
Three Lakes Drive, Northfield, IL 60093 USA
Made in USA
www.medline.com
1-800-MEDLINE
REF: HHRUB04
RC20HND
PACKAGE LABEL
Medline Industries, LP
MEDLINE
ethyl alcohol liquid
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:53329-022
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
ALCOHOL
80 mL in 100 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:53329-022-
04
11