ALCARE OR FOAMED ANTISEPTIC HANDRUB- alcohol aerosol, foam
STERIS Corporation

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.

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Alcare OR® Foamed Antiseptic Handrub

Drug Facts

Active ingredient

62% v/v Ethyl Alcohol

Purposes

Antiseptic

Uses

Surgical Scrub significantly reduces the number of micro-organisms on the hands and forearms prior to surgery or patient care.
Healthcare Personnel Handwash to decrease transient bacteria on the skin before contact with patients under medical care or treatment.

Warnings

Flammable, keep away from fire or flame. For external use only. Avoid contact with eyes. Eye irritant. If splashed in eyes, rinse promptly and thoroughly with water.

Discontinue use if irritation and redness develop.

If irritation persists for more than 3 days, consult a physician.

Keep this and all drugs out of the reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Contents under pressure. Do not puncture or incinerate. Do not store above 120˚F (49˚C). For best foam density store and use at 55 - 85˚F (13 - 29˚C).

Directions

Surgical Scrub

Clean under nails with a pick. Nails should be maintained with a 1 mm free edge. Dispense 5 grams (tennis ball) onto one hand. Spread on both hands, paying particular attention to the nails, cuticles, and interdigital spaces and forearms. Rub into skin until dry. Dispense 2.5 grams (golf ball) onto one hand and spread over both hands to the wrists and rub into the skin until dry.

Healthcare Personnel Handwash

Dispense a palm full (golf ball) in one hand. Spread over both hands up to one-half inch above the wrists. Rub vigorously.

Inactive ingredients

Water, Hydrofluorocarbon 152A, Isobutane, Emulsifying Wax, Polyquaternium-6, Sodium Benzoate, Propane, Sodium Sesquicarbonate

Questions or comments?

800-548-4873

PRINCIPAL DISPLAY PANEL - 482 g Can Label

NDC 0519-6396-80

ALCARE OR®

Foamed Antiseptic Handrub

Net Weight: 482g (17 oz)

6396-80

62% Ethyl Alcohol by Volume
No-Rinse Surgical Scrub and Healthcare Personnel Handwash
Mild, Moisturizing Formulation
Broad-Spectrum Antimicrobial Activity

Alcare OR is dispensed as a foam. It is
recommended for repeated use and requires
no water.

Alcare OR may be used as Surgical Scrub or
Healthcare Personnel Handwash in patient
care and other high risk settings to reduce
transient bacteria and the risk of cross
contamination.

For Hospital and Professional Use Only

STERIS®

Manufactured for:
STERIS Corporation
7501 Page Avenue
St. Louis, MO 63133 USA
800-548-4873 www.steris.com

6396-71E(213)
Product Made in U.S.A.

Principal Display Panel - 482 g Can Label

ALCARE OR FOAMED ANTISEPTIC HANDRUB
alcohol aerosol, foam

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:0519-6396
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (ALCOHOL)	ALCOHOL	62 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
WATER
1,1-DIFLUOROETHANE
ISOBUTANE
POLYQUATERNIUM-6 (15000 MW)
SODIUM BENZOATE
PROPANE
SODIUM SESQUICARBONATE

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0519-6396-80	482 g in 1 CAN

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part333E	02/08/2005

Labeler - STERIS Corporation (139424188)

Name	Address	ID/FEI	Business Operations
Establishment
Accra Pac, Inc.		024213616	MANUFACTURE(0519-6396)

Revised: 3/2013

Document Id: 1150e802-52de-4c71-b801-55ade1c40e98

Set id: c933bfa9-e1b1-4792-ade3-9c5b8242337d

Version: 1

Effective Time: 20130328

STERIS Corporation