FDA.reportPublic FDA data

Certus Alcohol Prep

Manufacturer
Certus Medical, Inc.
Effective date
2018-11-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:57:23

Label at a glance#

ProductCertus Alcohol Prep
Active ingredientISOPROPYL ALCOHOL
Label structure11 sections

Indications and uses

For preparation of the skin prior to an injection

Label contents#

Full prescribing information#

Drug Facts Box OTC-Active Ingredient Section

OTC - ACTIVE INGREDIENT SECTION

Isopropyl Alcohol 70% v/v

Drug Facts Box OTC-Purpose Section

OTC - PURPOSE SECTION

Antiseptic

Drug Facts Box OTC-Indications and Usage Section

INDICATIONS & USAGE SECTION

For preparation of the skin prior to an injection

Drug Facts Box OTC-Warnings Section

WARNINGS SECTION

for external use only

flammable, keep away from fire or flame

Drug Facts Box OTC-Do Not Use Section

OTC - DO NOT USE SECTION

with electrocautery procedures

in the eyes

if contact occurs , flush eyes with water

Drug Facts Box OTC-Stop Use Section

OTC - STOP USE SECTION

if irritation and redness develop

if condition persists consult your health care practitioner

Drug Facts Box OTC-Keep Out Of Reach Of Children Section

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

if swallowed get medical help or call a Poison Control Center right away

Drug Facts Box OTC-Dosage & Administration Section

DOSAGE & ADMINISTRATION SECTION

wipe injection site vigorously and discard

Drug Facts Box OTC-General Precautions Section

GENERAL PRECAUTIONS SECTION

Store at room temperature 15 degrees - 30 degrees C (59 degrees - 86 degrees F)

Drug Facts Box OTC-Inactive Ingredient Section

INACTIVE INGREDIENT SECTION

purified water

Certus Alcohol Prep Pad 210000 pouch

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

product labelproduct label

Certus Alcohol Prep Pad  

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
797544isopropyl alcohol 70 % Medicated PadPSN2
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCD2
797544isopropyl alcohol 70 % Medicated PadSY2
797544isopropyl alcohol 70 % Topical ClothSY2
797544isopropyl alcohol 70 % Topical SwabSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75990-3018-32020-01-31C16284748780-19d75b9d0-3898-f424-e053-dadaa90a57ceCertus Alcohol Prep Pad 210000 Drug Facts and Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75990-3018-3Certus Alcohol Prep0.4 mL in 1 POUCHSWAB0.42

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75990-3018CERTUS ALCOHOL PREP (ISOPROPYL ALCOHOL) SWAB [CERTUS MEDICAL, INC.]2Legacy NDC, 1 package rows20181127_b65e3c43-1fdf-46b7-83d3-49dc44d4611b.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ISOPROPYL ALCOHOLACTIVE INGREDIENTND2M4163021
ISOPROPYL ALCOHOLACTIVE MOIETYND2M4163021
WATERINACTIVE INGREDIENT059QF0KO0R1

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
75990-301875990-3018-3

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
ISOPROPYL ALCOHOLND2M416302ACTIB
WATER059QF0KO0RIACT

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
5c56f6a4-1345-454a-8185-ae8a89d48545b65e3c43-1fdf-46b7-83d3-49dc44d4611b2018-11-26WarningsExact identifier
spl id: 5c56f6a4-1345-454a-8185-ae8a89d48545
spl set id: b65e3c43-1fdf-46b7-83d3-49dc44d4611b

Reported adverse events (FAERS/openFDA)#

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