Label: SURGICEPT WATERLESS, SURGICAL HANDSCRUB AND HEALTHCARE PERSONNEL HANDWASH- ethyl alcohol solution

  • 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.

Drug Label Information

Updated September 11, 2017

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  • Drug Facts

  • Active ingredient

    Ethyl alcohol 70% w/w

  • Purpose

    Antiseptic

  • Uses

    • Surgical Hand Scrub:  Significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care.
    • Healthcare Personnel Handwash:  Handwash to help reduce bacteria that potentially can cause disease.  Recommended for repeated use.
  • Warnings

    • Flammable, keep away from fire or flame.
    • For external use only.
    • Do not use
      • if you are allergic to or have a known or suspected hypersensitivity to any ingredient in this product.
      • on or near the eyes, mucous membranes or mouth.  If product gets into the eyes, flush immediately with water.
    • Stop use and ask a doctor if irritation, redness or allergic reaction occurs.
    • Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Surgical Hand Scrub:  Clean under nails with a nail pick.  Nails should be maintained with a 1mm free edge.  Apply to clean, dry hands. (1) Dispense sufficient quantity of SURGICEPT to cover one hand (approx. 2ml) into cupped palm.  Dip the fingertips of your opposite hand into SURGICEPT and work under the nails.  Spread remainder of SURGICEPT on hand and lower two-thirds of forearm.  (2) Repeat Step 1 with other hand and forearm.  (3) Dispense an additional sufficient quantity (approx. 2ml) of SURGICEPT and apply to all surfaces of hands up to wrists, paying particular attention to nails, cuticles, and interdigital spaces.  Allow to dry before donning gloves.  Do not dry with a towel.
    • Healthcare Personnel Handwash:  Wet hands thoroughly with SURGICEPT and allow to dry without wiping.

  • Other information

    • Store upright at 20-25°C (68-77°F)
    • Avoid freezing and excessive heat.
    • Protect from light until use.
  • Inactive ingredients

    Behentrimonium methosulfate, benzalkonium chloride, butylene glycol, cetyl alcohol, chlorhexidine gluconate, ethylhexylglycerin, isopropyl alcohol, phenoxyethanol, polyquaternium-10, PPG-3 myristyl ether, water.

  • Questions?

    Please call 1-800-523-0502 (M-F 8 a.m.-5 p.m. CST) or visit our web site www.surgicept.com.

    PRINCIPAL DISPLAY PANEL

    NDC 0064-1080-59

    Surgicept ®

    Ethyl alcohol 70% w/w

    WATERLESS Surgical Hand Scrub & Healthcare Personnel Handwash

    2 fl oz (59 ml)
    129464-1010

    Marketed by:
    CareFusion, Leawood, KS 66211

    Manufactured for:
    Healthpoint, Ltd., Fort Worth, TX 76107
    by DPT Laboratories, Ltd., San Antonio, TX 78215

    REORDER NO. 0064-1080-59
    PATENT NO. 6,846,846

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    5503959a-figure-01
  • INGREDIENTS AND APPEARANCE
    SURGICEPT   WATERLESS, SURGICAL HANDSCRUB AND HEALTHCARE PERSONNEL HANDWASH
    ethyl alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0064-1080
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.75 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYQUATERNIUM-10 (400 CPS AT 2%) (UNII: HB1401PQFS)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Colorwhite (CLEAR) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0064-1080-5959 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2006
    2NDC:0064-1080-111150 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product01/01/2006
    3NDC:0064-1080-801 in 1 CARTON01/01/200602/28/2015
    3800 mL in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E01/01/2006
    Labeler - HEALTHPOINT, LTD (965634504)
    Establishment
    NameAddressID/FEIBusiness Operations
    DPT LABORATORIES, LTD832224526manufacture(0064-1080)
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