MOSAIC Hand Sanitizer by Zhejiang Meizhiyuan Cosmetics Co.,Ltd

MOSAIC Hand Sanitizer by

Drug Labeling and Warnings

MOSAIC Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Zhejiang Meizhiyuan Cosmetics Co.,Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MOSAIC HAND SANITIZER- alcohol spray 
Zhejiang Meizhiyuan Cosmetics Co.,Ltd

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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Active Ingredient

Ethyl alcohol 75% ± 5% (v/v)

Purpose

Antimicrobial

Use

Hand sanitizer to help reduce bacterial on skin that may cause disease

Warnings

• For external use only.
• FLAMMABLE: Keep away from open flame.
• WHEN USING THIS PRODUCT: Avoid contact with eyes and broken skin. In case of eye contact, flush with plenty of water and seek medical advice.

Stop use and ask doctor If, Irritation or redness develops.

Keep out of reach of children. If swallowed, get medical help or contact a poison control center.

Directions

Wet hands thoroughly with product and rub into skin until dry. Children 6 years and younger need adult supervision when using this product.

Inactive ingredients

Water (Aqua), Glycerin, Propylene Glycol, Carbomer, Triethanolamine, Fragrance, Aloe Barbadensis (Aloe Vera) Gel, Tocopheryl Acetate (Vitamin E)

Package Label - Principal Display Panel

MOSAIC HAND SANITIZER 
alcohol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80204-004
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)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TROLAMINE (UNII: 9O3K93S3TK)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80204-004-01	100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/26/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/26/2020	03/24/2024

Labeler - Zhejiang Meizhiyuan Cosmetics Co.,Ltd (543036597)

Establishment
Name	Address	ID/FEI	Business Operations
Zhejiang Meizhiyuan Cosmetics Co.,Ltd		543036597	manufacture(80204-004)

Revised: 11/2022

Document Id: 82b6371e-21b0-47c1-ba29-1febcce49fa9

34390-5

Set id: 76124bc2-cff5-45a4-ad2d-4331ecd7c154

Version: 3

Effective Time: 20221118