FDA.reportPublic FDA data

URIGEL 80% ALCOHOL SANITIZER GEL

Manufacturer
ANTISEPTICOS DE MEXICO SA DE CV
Effective date
2021-01-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:37:00

Label at a glance#

ProductURIGEL Hand Sanitizer
Active ingredientALCOHOL
Label structure18 sections

Dosage and administration

Place enough product on hands to cover all surfaces. Rub hands together until dry. 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#

SPL UNCLASSIFIED SECTION

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerol (1.45% v/v).
  3. Hydrogen peroxide (0.125% v/v).
  4. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 80% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer 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

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • 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

glycerin, hydrogen peroxide, purified water USP

URIGEL 3ML 80% HAND SANITIZER GEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3ML Packet 80%3ML Packet 80%3 mL NDC: 76554-007-01

URIGEL 60ML 80% HAND SANITIZER GEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Urigel 60ML GelUrigel 60ML Gel60ML NDC: 76554-007-02

URIGEL 250ML 80% HAND SANITIZER GEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Urigel 250ML GelUrigel 250ML Gel250ML NDC: 76554-007-03

URIGEL 500ML 80% HAND SANITIZER GEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Urigel 500ML GelUrigel 500ML Gel250ML NDC: 76554-007-03

URIGEL 1000ML/1LTR 80% HAND SANITIZER GEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Urigel 1000ML GelUrigel 1000ML Gel1000ML/1GAL NDC: 76554-007-05

URIGEL 3.75ML/1GAL 80% HAND SANITIZER GEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Urigel 3.75ML GelUrigel 3.75ML Gel3.75ML/1GAL NDC: 76554-007-10

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76554-007-012022-07-29C16284748780-1e4f33bdf-a281-d8a0-e053-dadaa90a6e4eURIGEL 80% ALCOHOL SANITIZER GEL
76554-007-022022-07-29C16284748780-1e4f33bdf-a281-d8a0-e053-dadaa90a6e4eURIGEL 80% ALCOHOL SANITIZER GEL
76554-007-032022-07-29C16284748780-1e4f33bdf-a281-d8a0-e053-dadaa90a6e4eURIGEL 80% ALCOHOL SANITIZER GEL
76554-007-042022-07-29C16284748780-1e4f33bdf-a281-d8a0-e053-dadaa90a6e4eURIGEL 80% ALCOHOL SANITIZER GEL
76554-007-052022-07-29C16284748780-1e4f33bdf-a281-d8a0-e053-dadaa90a6e4eURIGEL 80% ALCOHOL SANITIZER GEL
76554-007-102022-07-29C16284748780-1e4f33bdf-a281-d8a0-e053-dadaa90a6e4eURIGEL 80% ALCOHOL SANITIZER GEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76554-007-01URIGEL Hand Sanitizer3 mL in 1 PACKETGEL31
76554-007-02URIGEL Hand Sanitizer60 mL in 1 BOTTLEGEL601
76554-007-03URIGEL Hand Sanitizer250 mL in 1 BOTTLEGEL2501
76554-007-04URIGEL Hand Sanitizer500 mL in 1 BOTTLEGEL5001
76554-007-05URIGEL Hand Sanitizer1000 mL in 1 BOTTLEGEL10001
76554-007-10URIGEL Hand Sanitizer3750 mL in 1 BOTTLE, PUMPGEL37501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76554-007URIGEL HAND SANITIZER (ALCOHOL) GEL [ANTISEPTICOS DE MEXICO SA DE CV]1Legacy NDC, 6 package rows20210116_b8f58f8f-bf17-ea03-e053-2995a90a0a75.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76554-00776554-007-01, 76554-007-02, 76554-007-03, 76554-007-04, 76554-007-05, 76554-007-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
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
b8f58f47-295e-46b0-e053-2995a90aec49b8f58f8f-bf17-ea03-e053-2995a90a0a752021-01-15WarningsExact identifier
spl id: b8f58f47-295e-46b0-e053-2995a90aec49
spl set id: b8f58f8f-bf17-ea03-e053-2995a90a0a75

Reported adverse events (FAERS/openFDA)#

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