HAND SANITIZER - FOUR THIEVES BLEND- alcohol gel 
Mount Royal Soaps, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Hand Sanitizer - Four Thieves Gel Blend

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

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

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

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

Package Label - Principal Display Panel

Size: 59.1471 mL (2 Oz)

NDC: 74322-002-01

Label:

2 Oz 74322-002-01

Size: 118.294 mL (4 Oz)

NDC: 74322-002-02

Label:

4 Oz 74322-002-02

Size: 3785.41 mL (1 gal)

NDC: 74322-002-03

Label:

1 Gal 74322-002-03

HAND SANITIZER - FOUR THIEVES BLEND 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74322-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL63 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
LEMON OIL (UNII: I9GRO824LL) 0.19 mL  in 100 mL
ROSEMARY OIL (UNII: 8LGU7VM393) 0.13 mL  in 100 mL
TEA TREE OIL (UNII: VIF565UC2G) 0.13 mL  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK) 0.4 mL  in 100 mL
CLOVE OIL (UNII: 578389D6D0) 0.08 mL  in 100 mL
EUCALYPTUS OIL (UNII: 2R04ONI662) 0.11 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) 0.4 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 34 mL  in 100 mL
CINNAMON LEAF OIL (UNII: S92U8SQ71V) 0.06 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74322-002-0159.1471 mL in 1 BOTTLE; Type 0: Not a Combination Product04/03/2020
2NDC:74322-002-02118.294 mL in 1 BOTTLE; Type 0: Not a Combination Product04/03/2020
3NDC:74322-002-033785.41 mL in 1 JUG; Type 0: Not a Combination Product04/03/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/03/2020
Labeler - Mount Royal Soaps, LLC (081382906)
Registrant - Mount Royal Soaps, LLC (081382906)
Establishment
NameAddressID/FEIBusiness Operations
Charm City Meadworks051441049manufacture(74322-002) , pack(74322-002) , label(74322-002)
Establishment
NameAddressID/FEIBusiness Operations
Mount Royal Soaps, LLC081382906manufacture(74322-002) , pack(74322-002) , label(74322-002)

Revised: 4/2020
Document Id: a25f4843-41e3-223b-e053-2a95a90a4542
Set id: a25f5362-b868-5f47-e053-2995a90a05a7
Version: 1
Effective Time: 20200403
 
Mount Royal Soaps, LLC