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

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated January 14, 2022

If you are a consumer or patient please visit this version.

  • 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)