FDA.reportPublic FDA data

Sterile Alcohol Prep Pads

Manufacturer
Total Resources International | Shandong Haiyan Medical Manufacture Co. Ltd.
Effective date
2013-11-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:37:25

Label at a glance#

ProductSterile Alcohol Prep Pads
Active ingredientISOPROPYL ALCOHOL
Label structure9 sections

Indications and uses

Stop use and ask a doctor if: Irritation or redness develops condition persists for more than 72 hours Cleansing of an injection site

Dosage and administration

Wipe injection site vigorously and discard

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient                                       Purpose

Isopropyl Alcohol 70% v/v                         Antiseptic

Purpose: Sterile alcohol prep

OTC - PURPOSE SECTION

For preparation of the skin prior to injection.

Warnings:

WARNINGS SECTION

  • For external use only
  • Flammable, keep away from flame or fire
  • Not for use with electrocautinary devices or procedures
  • Do not use in eyes
  • Do not use if open or damaged.

Indications and Usage:

INDICATIONS & USAGE SECTION

Stop use and ask a doctor if:

  • Irritation or redness develops
  • condition persists for more than 72 hours
  • Cleansing of an injection site

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.

Directions:

DOSAGE & ADMINISTRATION SECTION

Wipe injection site vigorously and discard

Other information:

SPL UNCLASSIFIED SECTION

  • Store at room temperature: 15 deg C to 30 deg C   59 deg F to 86 deg F
  • avoid excessive heat

Inactive Ingredient

INACTIVE INGREDIENT SECTION

Inactive Ingredient

  • Water

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Total Resources International

Sterile Alcohol Prep Pad

TRI Sterile Alcohol Prep.jpg

Alcohol Prep padAlcohol Prep pad

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
797544isopropyl alcohol 70 % Medicated PadPSN1
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCD1
797544isopropyl alcohol 70 % Medicated PadSY1
797544isopropyl alcohol 70 % Topical ClothSY1
797544isopropyl alcohol 70 % Topical SwabSY1

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
55550-031-002020-01-31C16284748780-19d75b9cf-d9cd-f424-e053-dadaa90a57ceAlcohol Prep Pad

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55550-031-00Sterile Alcohol Prep Pads50 in 1 BOXLIQUID501
55550-031-00Sterile Alcohol Prep Pads0.45 mL in 1 PACKETLIQUID0.451

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55550-031STERILE ALCOHOL PREP PADS (ISOPROPYL ALCOHOL) LIQUID [TOTAL RESOURCES INTERNATIONAL]1Legacy NDC, 2 package rows20131112_4acaa680-51c4-403f-9350-5a5f9a47bc31.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
55550-03155550-031-00

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
f90ed16e-6c59-4c0b-86e1-00f8136914934acaa680-51c4-403f-9350-5a5f9a47bc312013-11-12WarningsExact identifier
spl id: f90ed16e-6c59-4c0b-86e1-00f813691493
spl set id: 4acaa680-51c4-403f-9350-5a5f9a47bc31

Reported adverse events (FAERS/openFDA)#

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