TRISEPTIN (ALCOHOL) LOTION [DFB TECHNOLOGY LTD]

TRISEPTIN (ALCOHOL) LOTION [DFB TECHNOLOGY LTD]
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NDC 70472-101-04
Set ID 9e576925-3519-4d07-b12e-5e3fe5460b96
Category HUMAN OTC DRUG LABEL
Packager DFB Technology Ltd
Generic Name
Product Class
Product Number
Application Number PART333E
  • SPL UNCLASSIFIED SECTION

    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 a doctor if:

    • irritation and redness develop
    • condition persists for more than 72 hours
  • Keep out of reach of chipdren.

    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. 
    • 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 upright at 20-25°C (68-77°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 1-800-323-9088 (M-F 8 a.m. - 5 p.m. CST).

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Becton Dickinson
    El Paso, TX 79912

    Manufactured for:
    DFB Technology, Ltd.
    Fort Worth, TX 76107
    by DPT Laboratories, Ltd.
    San Antonio, TX 78215
    4 fl oz (118 mL)
    140840-1116

  • PRINCIPAL DISPLAY PANEL

    NDC 70472-101-04
    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)
    140839-1116

    BD
    REORDER NO. 0064-1050-04

    PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Front Label 4 oz

    Back Label 4 oz Panel 1 of 3

    Back Label 4 oz Panel 2 of 3

    Back Label 4 oz Panel 3 of 3

  • INGREDIENTS AND APPEARANCE
    TRISEPTIN 
    alcohol lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70472-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 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:70472-101-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/15/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E09/15/2017
    Labeler - DFB Technology Ltd (965516164)
    Establishment
    NameAddressID/FEIBusiness Operations
    DPT Laboratories832224526manufacture(70472-101)

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