del Lago Resort and Casino Hand Santitizer

Manufacturer
Lago Resort & Casino, LLC
Effective date
2020-09-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:28:51

Label at a glance#

Productdel Lago Resort and Casino Hand Santitizer
Active ingredientALCOHOL
Label structure13 sections

Dosage and administration

Wet hands thoroughly with product, and allow to dry without wiping. For children under six, use only under adult supervision.

Storage and handling

Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F) May discolor some fabrics. Harmful to wood finishes and plastics

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) (70%, 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.
  5. Carbomer

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

For hand washing to decrease bacteria on the skin - Recommended for repeated use.

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 occurs. These may be signs of a serious condition.

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

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

Wet hands thoroughly with product, and allow to dry without wiping. For children under six, use only under adult supervision.

Other information

STORAGE AND HANDLING SECTION

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
  • May discolor some fabrics. Harmful to wood finishes and plastics

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, hydrogen peroxide, carbomer, and purified water USP

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package.Label Principal Display PanelPackage.Label Principal Display Panel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80431-001-012021-07-23C16284748780-1c7ccaba7-1bed-fd44-e053-dadaa90aa01bdel Lago Hand Sanitizer
80431-001-162021-07-23C16284748780-1c7ccaba7-1bed-fd44-e053-dadaa90aa01bdel Lago Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80431-001-01del Lago Resort and Casino Hand Santitizer3785 mL in 1 BOTTLEGEL37851
80431-001-16del Lago Resort and Casino Hand Santitizer500 mL in 1 BOTTLEGEL5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80431-001DEL LAGO RESORT AND CASINO HAND SANTITIZER (ALCOHOL) GEL [LAGO RESORT & CASINO, LLC]1Legacy NDC, 2 package rows20200910_ae5c98db-c5af-8f1f-e053-2995a90a1b58.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80431-00180431-001-01, 80431-001-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

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
ae5c98db-c5b0-8f1f-e053-2995a90a1b58ae5c98db-c5af-8f1f-e053-2995a90a1b582020-09-02WarningsExact identifier
spl id: ae5c98db-c5b0-8f1f-e053-2995a90a1b58
spl set id: ae5c98db-c5af-8f1f-e053-2995a90a1b58

Reported adverse events (FAERS/openFDA)#

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