Label: TRISEPTIN HAND AND BODY ANTISEPTIC- alcohol lotion

  • 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 January 4, 2012

If you are a consumer or patient please visit this version.

  • Drug Facts

  • Active ingredient

    Ethyl alcohol 70% v/v

  • PURPOSE

    Antiseptic

  • Uses

    Surgical Hand Scrub:

    • Significantly reduces the number of microorganisms on the hands, forearms and body prior to surgery or patient care.

    Patient Preoperative Skin Preparation:

    • For preparation of the skin prior to surgery or an injection.
    • Helps reduce bacteria that can potentially cause skin infection.
  • 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, genital skin, or mouth. If product gets into the eyes, flush immediately with water.
    • Avoid contact with broken skin.
    • Stop use and ask doctor if irritation and redness develop. If condition persists for more than 72 hours consult a physician.
    • 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 1 mm free edge.
    • Wet hands and forearms.
    • Dispense palmful (approx. 7 ml) of TRISEPTIN Scrub into the palm of one hand.
    • Twist fingertips of the opposite hand, working TRISEPTIN under the nails.
    • Transfer TRISEPTIN to the opposite hand and repeat with fingertips of the other hand.
    • Rub TRISEPTIN over the hands and up the forearms to just past the elbow, paying particular attention to the nails, cuticles and interdigital spaces for 90 seconds.
    • Rinse and repeat the procedure to just below the elbows. Rinse completely.

    Patient Preoperative Skin Preparation:

    • Apply to cleanse the surgical site and surrounding area 12 hours and 6 hours prior to surgery.
    • Clean the surgical area.
    • Place a palmful (approx. 7 ml) of TRISEPTIN to the surgical site and surrounding area and rub for 90 seconds paying particular attention to the surgical area.
    • Rinse and repeat.
    • Rinse completely.
  • Other information

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

    Benzethonium chloride, citric acid, cocamine oxide, fragrance, glyceryl laurate, hydroxypropylcellulose, phenylethyl alcohol, phosphoric acid, polyoxyl 40 stearate, propyl gallate, propylene glycol, purified water, zinc pyrithione.

    Questions?

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

    Marketed by:
    CareFusion
    Leawood, KS 66211

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

    REORDER NO. 0064-1050-04
    PATENT NO. 6,110,908

    4 fl oz (118 ml)
    129478-0411

    PRINCIPAL DISPLAY PANEL

    NDC 0064-1050-04

    Triseptin®
    Ethyl alcohol 70% v/v
    Hand & Body Antiseptic

    Surgical Hand Scrub

    • Used by surgeons in hospital operating rooms

    Patient Preoperative Skin Preparation

    • Helps reduce bacteria that can potentially cause skin infection
    • Alcohol and other skin-conditioning ingredients
    • Fast antibacterial action

    4 fl oz
    (118 ml)
    129477-0411

    CareFusion

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    39ef369b-figure-01
    39ef369b-figure-02
  • INGREDIENTS AND APPEARANCE
    TRISEPTIN  HAND AND BODY ANTISEPTIC
    alcohol lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0064-1050
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL.7 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZETHONIUM CHLORIDE (UNII: PH41D05744)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    COCAMINE OXIDE (UNII: QWA2IZI6FI)  
    GLYCERYL LAURATE (UNII: Y98611C087)  
    HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)  
    PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    PYRITHIONE ZINC (UNII: R953O2RHZ5)  
    Product Characteristics
    ColorWHITE (white to off-white) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0064-1050-04118 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/01/2002
    Labeler - HEALTHPOINT, LTD (965634504)
    Establishment
    NameAddressID/FEIBusiness Operations
    DPT LABORATORIES, LTD832224526MANUFACTURE