FDA.reportPublic FDA data

Alcohol Prep

Manufacturer
Custom Kits Company Inc
Effective date
2020-01-17
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:02:59

Label at a glance#

ProductAlcohol Prep
Active ingredientISOPROPYL ALCOHOL
Label structure11 sections

Indications and uses

Antiseptic Cleanser Kills harmful bacteria and germs First Aid to Help Prevent Infection

Dosage and administration

Use as a part of your daily cleansing routine May be covered with a sterile bandage

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Isopropyl Alcohol 70% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • Antiseptic Cleanser
  • Kills harmful bacteria and germs
  • First Aid to Help Prevent Infection

Warnings

WARNINGS SECTION

  • For External Use Only
  • Avoid contact with the eyes

If contact occurs, flush eyes with water

Flammable, keep away from flame or fire.

Do Not Use

OTC - DO NOT USE SECTION

With electrocautery, in the eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

Irritation and redness develops

If condition persists for more than 72 hours, consult a physician

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Use as a part of your daily cleansing routine

May be covered with a sterile bandage

Other Safety Information

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

Avoid Excess Heat

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

u1-25.jpgu1-25.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
797544isopropyl alcohol 70 % Medicated PadPSN4
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCD4
797544isopropyl alcohol 70 % Medicated PadSY4
797544isopropyl alcohol 70 % Topical ClothSY4
797544isopropyl alcohol 70 % Topical SwabSY4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68183-117-012022-01-28C16284748780-1d6a99b39-51dd-a426-e053-dadaa90af4c2Alcohol Prep Pads

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68183-117-01Alcohol Prep10 mL in 1 BOX, UNIT-DOSECLOTH104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68183-117ALCOHOL PREP (ISOPROPYL ALCOHOL) CLOTH [CUSTOM KITS COMPANY INC]4Legacy NDC, 1 package rows20200118_2229c23b-6796-4793-e054-00144ff8d46c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ISOPROPYL ALCOHOLACTIVE INGREDIENTND2M4163022
ISOPROPYL ALCOHOLACTIVE MOIETYND2M4163022
WATERINACTIVE INGREDIENT059QF0KO0R2

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
68183-11768183-117-01

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

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
7e031948-e09f-050e-e053-2a91aa0a1f1e2229c23b-6796-4793-e054-00144ff8d46c2020-01-17WarningsExact identifier
spl id: 7e031948-e09f-050e-e053-2a91aa0a1f1e
spl set id: 2229c23b-6796-4793-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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