TRISEPTIN HAND AND BODY ANTISEPTIC (ALCOHOL) LOTION [HEALTHPOINT, LTD]

TRISEPTIN HAND AND BODY ANTISEPTIC (ALCOHOL) LOTION [HEALTHPOINT, LTD]
PDF | XML

NDC 0064-1050-04
Set ID 757aed4e-43b9-4361-83bb-3fc4a6688d31
Category HUMAN OTC DRUG LABEL
Packager HEALTHPOINT, LTD
Generic Name
Product Class
Product Number
Application Number PART333E
  • 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

Related Drugs