FDA.reportPublic FDA data

Mt Royal Hand Sanitizer

Manufacturer
Mount Royal Soaps, LLC
Effective date
2025-05-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:57:57

Label at a glance#

ProductMt Royal Hand Sanitizer
Active ingredientALCOHOL
Label structure12 sections

Dosage and administration

Rub hands thoroughly with product and allow to dry.

Label contents#

Full prescribing information#

Product Decription & Introduction

SPL UNCLASSIFIED SECTION

This is a gel-form hand sanitizer (topical antiseptic rub) with a minimum of 62% Ethanol concentration and additional cosmetic fragrances manufactured in accordance with 21CFR330 and 21CFR333a.

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 62% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Decreases bacteria on hands

Warnings

WARNINGS SECTION

For external use only

Flammable

WARNINGS SECTION

Keep away from flame or high heat

OTC - WHEN USING SECTION

When using this product keep out of eyes. In case of contact with eyes, flush eyes with water. Avoid contact with broken skin.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or redness develop.

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

Rub hands thoroughly with product and allow to dry.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (aqua), Glycerine, Carbomer, Triethanolamine, Citrus Medica Limonum (Lemon) Peel Oil, Eugenia Caryophyllus (Clove) Flower Oil, Cinnamomum Zeylanicum (Cinnamon) Leaf Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Eucalyptus Globulus Leaf Oil

Initial Registration

RECENT MAJOR CHANGES SECTION

Updated label content sections from default content included in the COVID-19 Hand Sanitizer template to be consistent with product label.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Size: 59.1471 mL (2 Oz)

NDC: 74322-002-01

Label:

2 Oz 74322-002-012 Oz 74322-002-01

Size: 118.294 mL (4 Oz)

NDC: 74322-002-02

Label:

4 Oz 74322-002-024 Oz 74322-002-02

Size: 3785.41 mL (1 gal)

NDC: 74322-002-03

Label:

1 Gal 74322-002-031 Gal 74322-002-03

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74322-002-012022-01-28C16284748780-1d6a99b39-d5a3-a426-e053-dadaa90af4c2Mt Royal Hand Sanitizer
74322-002-022022-01-28C16284748780-1d6a99b39-d5a3-a426-e053-dadaa90af4c2Mt Royal Hand Sanitizer
74322-002-032022-01-28C16284748780-1d6a99b39-d5a3-a426-e053-dadaa90af4c2Mt Royal Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74322-004-01Mt Royal Hand Sanitizer0.398 kg in 1 BOTTLE, DISPENSINGGEL0.3982

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74322-00474322-004-01

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S)8Z5ZAL5H3VIACT
GLYCERINPDC6A3C0OXIACT
TRIETHANOLAMINE9O3K93S3TKIACT

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
Mt Royal Hand Sanitizer70% ETHYL ALCOHOL GELMount Royal Soaps, LLCa25f5362-b868-5f47-e053-2995a90a05a72025-05-01WarningsExact identifier
ndc (package): 74322-004-01
ndc (product): 74322-004
ndc11 (package): 74322000401
spl id: 32336cf3-dc07-7e3d-e063-6294a90a78ec
spl set id: a25f5362-b868-5f47-e053-2995a90a05a7

Reported adverse events (FAERS/openFDA)#

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