Product Decription & Introduction
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.
Mt Royal Hand Sanitizer Gel
FDA Label NDC 74322-004
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Mount Royal Soaps, Llc for the product Mt Royal Hand Sanitizer (NDC 74322-004). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding product decription & introduction, active ingredient(s), purpose, use, warnings, flammable, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient(S)
Ethyl Alcohol 62% v/v. Purpose: Antiseptic
Purpose
Antiseptic, Hand Sanitizer
Use
Decreases bacteria on hands
Warnings
For external use only
Flammable
Keep away from flame or high heat
Otc - When Using
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
Stop use and ask a doctor if irritation or redness develop.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Rub hands thoroughly with product and allow to dry.
Inactive Ingredients
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
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
Size: 59.1471 mL (2 Oz)
NDC: 74322-002-01
Label:
2 Oz 74322-002-01 (2oz Gel Label 04022020)
Size: 118.294 mL (4 Oz)
NDC: 74322-002-02
Label:
4 Oz 74322-002-02 (4oz Gel Label 04022020)
Size: 3785.41 mL (1 gal)
NDC: 74322-002-03
Label:
1 Gal 74322-002-03 (1gal Gel Label 04022020)
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