al-SHIELDS Hand Sanitizer by Zhejiang Meizhiyuan Cosmetics Co.,Ltd

al-SHIELDS Hand Sanitizer by

Drug Labeling and Warnings

al-SHIELDS 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]

AL-SHIELDS 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.

Warnings

For external use only.

Flammable. Keep away from fire or flame.

When using this product do not use in or near the eyes. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash appears and lasts.

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.

Other information

• Store below 105ºF (40ºC).
• May discolor certain fabrics.

Inactive ingradients

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

AL-SHIELDS HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80204-048
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)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
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: 80204-048-01	60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/28/2020
2	NDC: 80204-048-02	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/28/2020
3	NDC: 80204-048-03	300 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/28/2020
4	NDC: 80204-048-04	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/28/2020
5	NDC: 80204-048-05	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/28/2020
6	NDC: 80204-048-06	1000 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(80204-048)

Revised: 11/2022

Document Id: 2a698de9-5821-4d5a-ba0f-cee7c26950cb

34390-5

Set id: 47b732e0-caf7-46ca-b323-b0a4de1ab086

Version: 3

Effective Time: 20221118