ACST KIT (ANTIBODY COVID-19 SCREENING TEST KIT)- isopropyl alcohol 
Asclemed USA, Inc.

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.

----------

ACST Kit TM



(Antibody COVID-19 Screening Test Kit)

Active Ingredient                                   Purpose

Isopropyl Alcohol 70% v/v                       Antiseptic                          

Purpose:

Antiseptic

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

NDC: 76420-705-20


ACST Kit™
Antibody COVID-19 Screening Test Kit


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

Package Contains 20 Single Use Tests

For Professional Use Only
For In Vitro Diagnostic Use

Distributed by:
Enovachem™
PHARMACEUTICALS
Torrance, CA 90501

label

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:76420-705-201 in 1 POUCH; Type 1: Convenience Kit of Co-Package04/25/202006/26/2020
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 120 POUCH 100 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 other04/13/202006/26/2020
Labeler - Asclemed USA, Inc. (059888437)

Revised: 1/2021
Document Id: b98d602d-aa45-98dd-e053-2995a90a535a
Set id: 4def7ffa-0651-4c60-9d63-b300cca8afd9
Version: 2
Effective Time: 20210123
 
Asclemed USA, Inc.