TRISEPTIN WATER AIDED (ALCOHOL) LOTION [DFB TECHNOLOGY LTD]

TRISEPTIN WATER AIDED (ALCOHOL) LOTION [DFB TECHNOLOGY LTD]
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NDC 70472-102-32
Set ID cf2032eb-c9bd-4977-8707-f17e1e84fd91
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 and forearms prior to surgery or patient care.

  • 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
    • condition persists for more than 72 hours
  • Keep out of reach of children. 

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • 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.
  • 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


    32 fl oz (1 qt)

    (946 ml)
    140896-0417

  • PRINCIPAL DISPLAY PANEL

    NDC 70472-102-32

    Triseptin ®
    Ethyl alcohol 70% v/v
    WATER-AIDED
    Surgical Hand Scrub


    Alcohol with Persistence™

    Directions

    • 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.

    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.
    • or 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
    • condition persists for more than 72 hours.

    Read Drug Facts Before Use.

    32 fl oz (1 qt)

    (946 ml)
    140895-0417

    BD

    REORDER NO. 0064-1030-32

    PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    front

    back

  • INGREDIENTS AND APPEARANCE
    TRISEPTIN   WATER AIDED
    alcohol lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70472-102
    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:70472-102-32946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/25/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/25/2017
    Labeler - DFB Technology Ltd (965516164)
    Establishment
    NameAddressID/FEIBusiness Operations
    DPT Laboratories, Ltd.832224526manufacture(70472-102)

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