Your browser does not support JavaScript! ALCARE OR FOAMED ANTISEPTIC HANDRUB (ALCOHOL) AEROSOL, FOAM [STERIS CORPORATION]
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ALCARE OR FOAMED ANTISEPTIC HANDRUB (alcohol) aerosol, foam
[STERIS Corporation]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

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

Apply product to hands and rub until thoroughly dry.

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

Foamed
Antiseptic
Handrub

Alcare OR®

NDC 0519-6396-80

Hand Sanitizer

Excellent
Moisturization

Surgical Scrub

CHG Compatible

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

For Hospital and Professional Use Only.

Net Weight: 482g (17 oz)

REORDER #
6396-80

STERIS®

6396-71F(1113)
52374
Product Made in U.S.A.

Principal Display Panel- 482 g Can Label
ALCARE OR FOAMED ANTISEPTIC HANDRUB 
alcohol aerosol, foam
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0519-6396
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (ALCOHOL) ALCOHOL62 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER 
1,1-DIFLUOROETHANE 
ISOBUTANE 
CETOSTEARYL ALCOHOL 
POLYSORBATE 60 
POLYQUATERNIUM-6 (15000 MW) 
SODIUM BENZOATE 
PROPANE 
SODIUM SESQUICARBONATE 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0519-6396-9012 in 1 CASE
1NDC:0519-6396-80482 g in 1 CAN
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart333E02/08/2005
Labeler - STERIS Corporation (139424188)
Establishment
NameAddressID/FEIBusiness Operations
Accra Pac, Inc.024213616MANUFACTURE(0519-6396)

Revised: 2/2014
 
STERIS Corporation

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