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

ACST Kit (Antibody COVID-19 Screening Test Kit) by

Drug Labeling and Warnings

ACST Kit (Antibody COVID-19 Screening Test Kit) by is a Otc medication manufactured, distributed, or labeled by Asclemed USA, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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: 76420-705-20

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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76420-705

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76420-705-20	1 in 1 POUCH; Type 1: Convenience Kit of Co-Package	04/25/2020

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	20 POUCH	100 mL

Part 1 of 1

ISOPROPYL ALCOHOL 
isopropyl alcohol swab

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		5 mL in 1 POUCH; 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	01/01/2007

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		04/13/2020

Labeler - Asclemed USA, Inc. (059888437)