Premium Nature hand sanitizer by Zhejiang Meizhiyuan Cosmetics Co.,Ltd

Premium Nature hand sanitizer by

Drug Labeling and Warnings

Premium Nature 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]

PREMIUM NATURE HAND SANITIZER- alcohol gel 
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% v/v.

Purpose

Antimicrobial

Use

Hand Sanitizer to help reduce bacteria on the skin that may cause disease.

Warnings

For external use only. Flammable. Keep away from heat or flame

When using this product avoid contact with face, eyes and broken skin. In case of eye contact, flush with plenty of water and seek medical advice.
Stop use and ask a doctor if irritation or redeness 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 the into skin until dry.
• children under 6 years of age should be supervised by an adult when using.

Other information

• Store below 110 F (43C).
• May discolor certain fabrics or surfaces.

Inactive ingredients

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

Package Label - Principal Display Panel

PREMIUM NATURE HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80204-011
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)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80204-011-01	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/28/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/28/2020	03/24/2024

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

Establishment
Name	Address	ID/FEI	Business Operations
Zhejiang Meizhiyuan Cosmetics Co.,Ltd		543036597	manufacture(80204-011)

Revised: 11/2022

Document Id: 945cdcb6-9fb3-436b-bb69-74aee77f0cd4

34390-5

Set id: 2ec76cef-9db6-4711-a6bd-018a830b9cc1

Version: 3

Effective Time: 20221118