FDA Label for Hand Sanitizer - Four Thieves Blend
View Indications, Usage & Precautions
Hand Sanitizer - Four Thieves Blend Product Label
The following document was submitted to the FDA by the labeler of this product Mount Royal Soaps, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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.
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:
Size: 118.294 mL (4 Oz)
NDC: 74322-002-02
Label:
Size: 3785.41 mL (1 gal)
NDC: 74322-002-03
Label:
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