FDA.reportPublic FDA data

ACST Kit (Antibody COVID-19 Screening Test Kit)

Manufacturer
Asclemed USA, Inc.
Effective date
2022-01-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:16:39

Label at a glance#

ProductACST Kit (Antibody COVID-19 Screening Test Kit)
Active ingredientISOPROPYL ALCOHOL
Label structure8 sections

Dosage and administration

apply to skin as needed discard after single use

Storage and handling

Protect from freezing and avoid excessive heat

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient                                   Purpose

Isopropyl Alcohol 70% v/v                       Antiseptic                          

OTC - PURPOSE SECTION

Purpose:

Antiseptic

INDICATIONS & USAGE SECTION

Uses

For first aid to decrease germs in

  • minor cuts
  • scrapes
  • burns

For preparation of the skin prior to injection

Warnings

WARNINGS SECTION

For external use only

Flammable - keep away from fire or flame

Do not use

OTC - DO NOT USE SECTION

with electrocautery procedures

When using this product do not

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

  • 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply to skin as needed
  • discard after single use

Other information

STORAGE AND HANDLING SECTION

Protect from freezing and avoid excessive heat

Inactive ingredient

INACTIVE INGREDIENT SECTION

Water

PACKAGE LABEL.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

labellabel

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-705-20EA - Each76420-70524bbbff7-21db-4625-9b17-1ab55d12e60412020-06-05
76420-705-25EA - Each76420-70553bc5490-fff4-4308-97d9-8d9a086c70a112020-06-05

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76420-70576420-705-25

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ISOPROPYL ALCOHOLND2M416302ACTIB

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d597b57d-3898-b0ec-e053-2a95a90ad440918e29ec-20fa-4e45-9f93-7bde16d5cac02022-01-14WarningsExact identifier
spl id: d597b57d-3898-b0ec-e053-2a95a90ad440
spl set id: 918e29ec-20fa-4e45-9f93-7bde16d5cac0

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.