Label: ACST KIT (ANTIBODY COVID-19 SCREENING TEST KIT)- isopropyl alcohol kit

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Updated January 14, 2022

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  • ACTIVE INGREDIENT

    Active Ingredient                                   Purpose

    Isopropyl Alcohol 70% v/v                       Antiseptic                          

  • PURPOSE

    Purpose:

    Antiseptic

  • INDICATIONS & USAGE

    Uses

    For first aid to decrease germs in

    • minor cuts
    • scrapes
    • burns

    For preparation of the skin prior to injection

  • Warnings

    For external use only

    Flammable - keep away from fire or flame

    Do not use

    with electrocautery procedures

    When using this product do not

    • get into eyes
    • apply over large areas of the body
    • in case of deep or puncture wounds, animal bites or serious burns consult a doctor

    Stop use and ask a doctor if

    • condition persists or gets worse or lasts for more than 72 hours
    • do not use longer than 1 week unless directed by a doctor

    Keep out of reach of children.

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

  • Directions

    • apply to skin as needed
    • discard after single use
  • Other information

    Protect from freezing and avoid excessive heat

  • Inactive ingredient

    Water

  • PRINCIPAL DISPLAY PANEL

    NDC: 76420-705-25


    ACST Kit™
    Antibody COVID-19 Screening Test Kit


    Kit Contains
    25 Test Cassettes with Buffer and Package Insert
    25 Droppers
    25 Isopropyl Alcohol 70% Prep Pads
    25 Single Use Lancets
    25 Biohazard Specimen Bags
    25 Adhesive Bandages

    Package Contains 25 Single Use Tests

    For Professional Use Only
    For In Vitro Diagnostic Use

    Distributed by:
    Enovachem™
    PHARMACEUTICALS
    Torrance, CA 90501

    label

  • INGREDIENTS AND APPEARANCE
    ACST KIT (ANTIBODY COVID-19 SCREENING TEST KIT) 
    isopropyl alcohol kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76420-705
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76420-705-251 in 1 POUCH; Type 1: Convenience Kit of Co-Package04/25/202004/30/2022
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 125 POUCH 125 mL
    Part 1 of 1
    ISOPROPYL ALCOHOL 
    isopropyl alcohol swab
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    15 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/01/2007
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/13/202004/30/2022
    Labeler - Asclemed USA, Inc. (059888437)
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