FDA.reportPublic FDA data

Sanitizing Alcohol Wipes

Manufacturer
Unitrex Ltd.
Effective date
2023-01-04
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 21:41:44

Label at a glance#

ProductSanitizing Alcohol Wipes
Active ingredientISOPROPYL ALCOHOL
Label structure11 sections

Dosage and administration

Wet hands thoroughly with product and allow to dry. Discard wipe in trash receptacle after use. Do not flush. Children under 6 years of age should be supervised when using this product.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Isopropyl Alcohol 75% v/v

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Use

INDICATIONS & USAGE SECTION

To help reduce bacteria, fungi, and viruses on the skin

Warnings

WARNINGS SECTION

For external use only.

Flammable. Keep away from heat or flame.

Do not use

OTC - DO NOT USE SECTION

Do not use in the eyes. In case of eye contact, rinse eyes thoroughly with water.

Stop use

OTC - STOP USE SECTION

Discontinue use if irritation or redness develops. If condition persists for more than 72 hours, consult a doctor.

Keep out of reach of children

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

  • Wet hands thoroughly with product and allow to dry.
  • Discard wipe in trash receptacle after use. Do not flush.
  • Children under 6 years of age should be supervised when using this product.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Distilled Water

SPL UNCLASSIFIED SECTION

sparoom

SANITIZING ALCOHOL WIPES

Kills 99.99% of Common Germs

Isopropyl Alcohol 75%

Storage Conditions:

Store in a cool and dry environment. Avoid high temperature environment and keep away from fire sources.

Shelf Life:

  • Sealed / Unopened: 2 years
  • Opened: 90 Days

Distributed by Unitrex Ltd. / SpaRoom
5060 Taylor Rd, Cleveland OH 44128
© 2020 Unitrex
Questions? Toll-Free 1-833-729-4859
Made in China

80 PCS Container

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78553-3910-12023-01-04C16284748780-1e4f33bdf-b1aa-d8a0-e053-dadaa90a6e4eAlcohol Wipes
78553-3910-12022-07-29C16284748780-1e4f33bdf-b1aa-d8a0-e053-dadaa90a6e4eAlcohol Wipes

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
78553-391078553-3910-1

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
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
f17242c8-6e53-5b70-e053-2a95a90ac332a733ddaf-5e14-381f-e053-2995a90a286e2023-01-04WarningsExact identifier
spl id: f17242c8-6e53-5b70-e053-2a95a90ac332
spl set id: a733ddaf-5e14-381f-e053-2995a90a286e

Reported adverse events (FAERS/openFDA)#

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