MAJESTIC INSTANT HAND SANITIZER- ethyl alcohol gel

Majestic Instant Hand Sanitizer by

Drug Labeling and Warnings

Majestic Instant Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Global Cosmetics (China) Company Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Ethyl Alcohol 75% v/v

Purpose

Antimicrobial

INDICATIONS & USAGE

Uses: Hand Sanitizer to help reduce bacteria on skin.

WARNINGS

Warnings: Flammable. Keep away from fire or flame. For external use only.

Do not use

In Children less than 2 months of age

on open skin

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.

Directions:

Place enough product on hands to cover all surfaces. Rub hand together until dry

Supervise children under 6 years of age when using this product to avoid swallowing

Other Information:

Store between 15-30°C (59-86°F)

Avoid freezing and excessive heat above 40°C (104°F)

INACTIVE INGREDIENT

Inactive Ingredients: Aqua, Glycerin, Carbomer, Triethanolamine, Tocopheryl Acetate, Centella Asiatica Extract, Aloe Barbadensis Leaf Juice, Citric Acid.

SPL UNCLASSIFIED SECTION

Brought to you by clinicians with your well-being in mind.

Kills 99.9% of germs

Contains 75% Alcohol

Suitable for hand cleaning

Cleans and disinfects

Distributed by
Majestic Group LLC
5006 Herzel Place
Beltsville Maryland 20705

Email: sales@majestiicsuppliers.com

Website: www.majesticsuppliers.com

Phone: +1 (301) 792-2121

Made in China

Packaging

INGREDIENTS AND APPEARANCE

MAJESTIC INSTANT HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71650-008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CENTELLA ASIATICA WHOLE (UNII: 7M867G6T1U)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71650-008-01	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/08/2020
2	NDC: 71650-008-02	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/08/2020
3	NDC: 71650-008-03	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/08/2020
4	NDC: 71650-008-04	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/08/2020
5	NDC: 71650-008-05	5000 mL in 1 CAN; Type 0: Not a Combination Product	05/08/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/08/2020

Labeler - Global Cosmetics (China) Company Limited (527852739)

Establishment
Name	Address	ID/FEI	Business Operations
Global Cosmetics (China) Company Limited		527852739	manufacture(71650-008)