W1120 - TRACHEOSTOMY CARE PACK () KIT [SMITHS MEDICAL ASD, INC.]

W1120 - TRACHEOSTOMY CARE PACK () KIT [SMITHS MEDICAL ASD, INC.]
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NDC 51688-0124-4, 52380-0013-1
Set ID 832c1535-e2fd-47fb-b243-8ae2776b1f1c
Category MEDICAL DEVICE
Packager Smiths Medical ASD, Inc.
Generic Name
Product Class
Product Number
Application Number K965017
  • ACTIVE INGREDIENT

    Hydrogen Peroxide USP 3%


    Purpose
    Antiseptic

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  • WARNINGS

    For external use only.


    Ask a doctor before use if injuries are

    • deep or puncture wounds
    • serious burns

    Stop use and ask a doctor if

    • infection occurs
    • redness, irritation, swelling or pain persists or increases

    Keep out of reach of children. In case of accidental ingestions, seek professional assistance or consult a poison control center immediately.

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  • QUESTIONS

    Questions or comments?1 800 760-3236 (Monday-Friday 8:30 AM-5:00 PM EST)

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  • DOSAGE & ADMINISTRATION

    Apply locally as needed.

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  • INACTIVE INGREDIENT

    • water
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  • INDICATIONS & USAGE

    Topical anti-infective

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  • PRINCIPAL DISPLAY PANEL

    Hydrogen Peroxide Packet

    DR021-Hydrogen Peroxide Label.jpg

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  • INGREDIENTS AND APPEARANCE
    W1120 - TRACHEOSTOMY CARE PACK 
    anesthesia conduction kit kit
    Product Information
    Product Type MEDICAL DEVICE Item Code (Source) NHRIC:51688-0124
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NHRIC:51688-0124-4 20 in 1 CASE
    1 1 in 1 PACKAGE, COMBINATION
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 1 PACKAGE 30 mL
    Part 1 of 1
    APLICARE HYDROGEN PEROXIDE 
    hydrogen peroxide liquid
    Product Information
    Item Code (Source) NDC:52380-0013
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE 3 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    water (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52380-0013-1 30 mL in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 12/01/1983
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    premarket notification K965017 01/30/2007
    Labeler - Smiths Medical ASD, Inc. (137835299)
    Establishment
    Name Address ID/FEI Business Operations
    Smiths Medical ASD, Inc. 137835299 manufacture
    Establishment
    Name Address ID/FEI Business Operations
    Aplicare, Inc. 081054904 manufacture, repack
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