FDA.reportPublic FDA data

SANITIZING ISOPROPYL ALCOHOL WIPES

Manufacturer
Unitrex Ltd. | Hangzhou Wellbeing Technology Co., Ltd.
Effective date
2020-08-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:26:03

Label at a glance#

ProductSANITIZING ISOPROPYL ALCOHOL WIPES
Active ingredientISOPROPYL ALCOHOL
Label structure12 sections

Dosage and administration

Wipe the surface of the skin with a damp paper towel until it is dry. Do not rinse with water immediately after wiping. Supervise children under 6 years of age when using this product to avoid swallowing.

Storage and handling

Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Isopropyl Alcohol 75% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Isopropyl alcohol Antiseptic Wipes to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame

Do not use

OTC - DO NOT USE SECTION

  • in children less than 2 months of age
  • on open skin wounds

OTC - WHEN USING SECTION

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Wipe the surface of the skin with a damp paper towel until it is dry. Do not rinse with water immediately after wiping.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

STORAGE AND HANDLING SECTION

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

purified water USP

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

80 Wipes NDC: 78553-3920-1 Package LabelPackage Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2287160isopropyl alcohol 75 % Medicated PadPSN1
2287160isopropyl alcohol 0.75 ML/ML Medicated PadSCD1
2287160isopropyl alcohol 75 % Topical ClothSY1
2287160isopropyl alcohol 75 % Topical SwabSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78553-3920-12022-07-29C16284748780-1e4f33bdf-a003-d8a0-e053-dadaa90a6e4eadd2d92d-7159-94d7-e053-2a95a90ad948

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78553-3920-1SANITIZING ISOPROPYL ALCOHOL WIPES370 g in 1 CANCLOTH3701

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78553-3920SANITIZING ISOPROPYL ALCOHOL WIPES (HAND SANITIZER) CLOTH [UNITREX LTD.]1Legacy NDC, 1 package rows20200828_add2d92d-7159-94d7-e053-2a95a90ad948.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78553-392078553-3920-1

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

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
add2d45e-4d4d-8c88-e053-2995a90a75ceadd2d92d-7159-94d7-e053-2a95a90ad9482020-08-27WarningsExact identifier
spl id: add2d45e-4d4d-8c88-e053-2995a90a75ce
spl set id: add2d92d-7159-94d7-e053-2a95a90ad948

Reported adverse events (FAERS/openFDA)#

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