FDA.reportPublic FDA data

Canyon Diablo Spirits Hand Sanitizer

Manufacturer
Canyon Diablo Spirits, LLC
Effective date
2020-05-22
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-05-31 23:14:18

Label at a glance#

ProductCanyon Diablo Spirits Hand Sanitizer
Active ingredientALCOHOL
Label structure14 sections

Dosage and administration

Directions

Storage and handling

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

Label contents#

Full prescribing information#

SPL Unclassified

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.

SPL UnclassifiedSPL Unclassified

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 80% v/v. Purpose: Antisepc

Active Ingredient(s)Active Ingredient(s)

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

purposepurpose

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Use(s)Use(s)

Warnings

WARNINGS SECTION

For external use only. Flammabl2. Keep away from heat or flame

WarningsWarnings

Do not use

OTC - DO NOT USE SECTION

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

Do Not UseDo Not Use

When using

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.

When UsingWhen Using

Stop use

OTC - STOP USE SECTION

Stop use

Stop UsingStop Using

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.

Keep Out of Reach of ChildrenKeep Out of Reach of Children

Other information

STORAGE AND HANDLING SECTION

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

Other InformationOther Information

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, hydrogen peroxide, purified water USP

Inactive IngredientsInactive Ingredients

Dosage and Administrion

RECENT MAJOR CHANGES SECTION

Uses

UsesUses

Directions

DOSAGE & ADMINISTRATION SECTION

Directions

DirectionsDirections

Package Label - Principal Display Panel and Front Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

(Canyon Diablo Spirits logo)

HAND SANITIZER

Alcohol Antiseptic 80%

Topical Solution

Non-sterile Solution

NET 3785 ML (128 FL OZ)

Front LabelFront Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039339ethanol 80 % Topical SolutionPSN7
1039339ethanol 0.8 ML/ML Topical SolutionSCD7
1039339ethanol 80 % Topical SolutionSY7

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74396-001-012022-01-28C16284748780-1d6a99b39-f42c-a426-e053-dadaa90af4c2Hand Sanitizer
74396-001-022022-01-28C16284748780-1d6a99b39-f42c-a426-e053-dadaa90af4c2Hand Sanitizer
74396-001-042022-01-28C16284748780-1d6a99b39-f42c-a426-e053-dadaa90af4c2Hand Sanitizer
74396-001-052022-01-28C16284748780-1d6a99b39-f42c-a426-e053-dadaa90af4c2Hand Sanitizer
74396-001-062022-01-28C16284748780-1d6a99b39-f42c-a426-e053-dadaa90af4c2Hand Sanitizer
74396-001-072022-01-28C16284748780-1d6a99b39-f42c-a426-e053-dadaa90af4c2Hand Sanitizer
74396-001-082022-01-28C16284748780-1d6a99b39-f42c-a426-e053-dadaa90af4c2Hand Sanitizer
74396-001-092022-01-28C16284748780-1d6a99b39-f42c-a426-e053-dadaa90af4c2Hand Sanitizer
74396-001-102022-01-28C16284748780-1d6a99b39-f42c-a426-e053-dadaa90af4c2Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74396-001-01Canyon Diablo Spirits Hand Sanitizer3785 mL in 1 JUGLIQUID37857
74396-001-02Canyon Diablo Spirits Hand Sanitizer473 mL in 1 BOTTLE, PLASTICLIQUID4737
74396-001-04Canyon Diablo Spirits Hand Sanitizer118 mL in 1 BOTTLE, PLASTICLIQUID1187
74396-001-05Canyon Diablo Spirits Hand Sanitizer236 mL in 1 BOTTLE, PLASTICLIQUID2367
74396-001-06Canyon Diablo Spirits Hand Sanitizer177 mL in 1 BOTTLE, PLASTICLIQUID1777
74396-001-07Canyon Diablo Spirits Hand Sanitizer946 mL in 1 BOTTLE, PLASTICLIQUID9467
74396-001-08Canyon Diablo Spirits Hand Sanitizer1893 mL in 1 BOTTLE, PLASTICLIQUID18937
74396-001-09Canyon Diablo Spirits Hand Sanitizer18297 mL in 1 CONTAINERLIQUID182977
74396-001-10Canyon Diablo Spirits Hand Sanitizer60 mL in 1 BOTTLE, PLASTICLIQUID607

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74396-001CANYON DIABLO SPIRITS HAND SANITIZER (ALCOHOL) LIQUID [CANYON DIABLO SPIRITS, LLC]7Legacy NDC, 9 package rows20200523_a23ea4d3-096c-3c62-e053-2995a90a4697.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
74396-00174396-001-01, 74396-001-02, 74396-001-04, 74396-001-05, 74396-001-06, 74396-001-07, 74396-001-08, 74396-001-09, 74396-001-10

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
a6410853-649d-d7f4-e053-2a95a90a6efda23ea4d3-096c-3c62-e053-2995a90a46972020-05-22WarningsExact identifier
spl id: a6410853-649d-d7f4-e053-2a95a90a6efd
spl set id: a23ea4d3-096c-3c62-e053-2995a90a4697

Reported adverse events (FAERS/openFDA)#

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