FDA.reportPublic FDA data

Antibacterial Alcohol Wipes

Manufacturer
Urigel | Urigel Inc | Antisépticos de México, S.A. de C.V.
Effective date
2021-01-06
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:36:36

Label at a glance#

ProductAntibacterial Alcohol Wipes
Active ingredientALCOHOL
Label structure15 sections

Dosage and administration

To use, pull out wipe and reseal container to maintain moisture. Unfold cloth and rub thoroughly over all surfaces of both hands. Use only once and dispose of wipein a trash receptacle. Do not flush. Rub hands together briskly to dry.

Storage and handling

Store between 59-86 °F (15-30 °C) Avoid freezing and excessive heat Dispose of contents/container responsibly

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

EthylAlcohol 80%. Purpose: Antibacterial

Purpose

OTC - PURPOSE SECTION

Antibacterial, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

For handwashing to decrease bacteria on skin.

Warnings

WARNINGS SECTION

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

Do not use

OTC - DO NOT USE SECTION

  • on children less than 2 months of age
  • on open skin wounds
  • over large areas of the body or if you are allergic to any of these ingredients.

OTC - WHEN USING SECTION

When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

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

  • To use, pull out wipe and reseal container to maintain moisture.
  • Unfold cloth and rub thoroughly over all surfaces of both hands. Use only once and dispose of wipein a trash receptacle.
  • Do not flush.
  • Rub hands together briskly to dry.

Other information

STORAGE AND HANDLING SECTION

  • Store between 59-86 °F (15-30 °C)
  • Avoid freezing and excessive heat
  • Dispose of contents/container responsibly

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin.

Principal Display Panel 450 units

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Main LabelMain Label

80 each Sanitizer Wipes

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Urigel Wipes 80 eachUrigel Wipes 80 each80 Each NDC: 80924-110-01

100 Each Sanitizer Wipes

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Urigel Wipes 100 eachUrigel Wipes 100 each100 Each NDC:80924-110-02

450 Sanitizer Wipes

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Urigel Wipes 450 eachUrigel Wipes 450 each450 Each NDC:80924-110-03

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1489307ethanol 70 % Medicated PadPSN5
1489307ethanol 0.7 ML/ML Medicated PadSCD5
1489307ethanol 70 % Medicated PadSY5
1489307ethanol 70 % Medicated WipesSY5
1489307ethyl alcohol 70 % ClothSY5

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80924-110-012022-07-29C16284748780-1e4f33bdf-aef6-d8a0-e053-dadaa90a6e4eAntibacterial Alcohol wipes 80U
80924-110-022022-07-29C16284748780-1e4f33bdf-aef6-d8a0-e053-dadaa90a6e4eAntibacterial Alcohol wipes 80U
80924-110-032022-07-29C16284748780-1e4f33bdf-aef6-d8a0-e053-dadaa90a6e4eAntibacterial Alcohol wipes 80U

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80924-110-01Antibacterial Alcohol Wipes80 g in 1 CANISTERCLOTH805
80924-110-02Antibacterial Alcohol Wipes100 g in 1 CANISTERCLOTH1005
80924-110-03Antibacterial Alcohol Wipes450 g in 1 CANISTERCLOTH4505

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80924-110ANTIBACTERIAL ALCOHOL WIPES (ALCOHOL) CLOTH [URIGEL]5Legacy NDC, 3 package rows20210108_b8474a3f-a7c1-3723-e053-2a95a90a909f.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
80924-11080924-110-03, 80924-110-01, 80924-110-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB

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
b847ac3f-c09e-ecba-e053-2995a90ae43bb8474a3f-a7c1-3723-e053-2a95a90a909f2021-01-06WarningsExact identifier
spl id: b847ac3f-c09e-ecba-e053-2995a90ae43b
spl set id: b8474a3f-a7c1-3723-e053-2a95a90a909f

Reported adverse events (FAERS/openFDA)#

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