Label: ALCARE OR FOAMED ANTISEPTIC HANDRUB- alcohol aerosol, foam
- NDC Code(s): 0519-6396-80, 0519-6396-90
- Packager: STERIS Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Updated February 20, 2014
If you are a consumer or patient please visit this version.
- SPL UNCLASSIFIED SECTION
- Active ingredient
62% v/v Ethyl AlcoholClose
- 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.
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.
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.
- STORAGE AND HANDLING
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).Close
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.
- Inactive ingredients
Water, Hydrofluorocarbon 152A, Isobutane, Emulsifying Wax, Polyquaternium-6, Sodium Benzoate, Propane, Sodium SesquicarbonateClose
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 482 g Can Label
7501 Page Avenue
St. Louis, MO 63133 ■ USA
For Hospital and Professional Use Only.
Net Weight: 482g (17 oz)
Product Made in U.S.A.
- INGREDIENTS AND APPEARANCE
ALCARE OR FOAMED ANTISEPTIC HANDRUB
alcohol aerosol, foam
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0519-6396 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 62 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) 1,1-DIFLUOROETHANE (UNII: 0B1U8K2ME0) ISOBUTANE (UNII: BXR49TP611) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) POLYSORBATE 60 (UNII: CAL22UVI4M) POLYQUATERNIUM-6 (15000 MW) (UNII: YFL33X52PX) SODIUM BENZOATE (UNII: OJ245FE5EU) PROPANE (UNII: T75W9911L6) SODIUM SESQUICARBONATE (UNII: Y1X815621J) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0519-6396-90 12 in 1 CASE 1 NDC:0519-6396-80 482 g in 1 CAN Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part333E 02/08/2005 Labeler - STERIS Corporation (139424188) Establishment Name Address ID/FEI Business Operations Accra Pac, Inc. 024213616 MANUFACTURE(0519-6396)