Edens Hand Sanitizer by Zhejiang Meizhiyuan Cosmetics Co., Ltd / Townley Inc. hand sanitizer -4611

Edens Hand Sanitizer by

Drug Labeling and Warnings

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

Drug Details [pdf]

EDENS HAND SANITIZER 01- 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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hand sanitizer -4611

Drug facts

Active Ingredient Purpose

Ethyl Alcohol 70% v/v ....Antimicrobial

USE

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

Warning

For external use only.

Flammable, Keep away from heat and 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 redness develops.

Keep out of reach of children.

If swallowed get immediate medical help or contact a poison control center.

Direction:

Wet hands with product and rub into skin until dry.

Children under 6 years of age should be supervised by an adult when using this product.

Other information

Store below 105 oF (40 oC). May discolot certain fabrics or surfaces.

Inactive Ingredients:

Water( aqua), Propylene Glycol, Glycerin, Carbomer, Fragrance, Aminomethyl Propanol, Aloe Barbadensis( Aloe Vera) Gel, Tocopheryl acetate( vitamin E).

EDENS HAND SANITIZER  01
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54304-074
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER 940 (UNII: 4Q93RCW27E)	0.3 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	0.5 mL  in 100 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	0.5 mL  in 100 mL
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)	0.14 mL  in 100 mL
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)	0.1 mL  in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X)	0.1 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	32.46 mL  in 100 mL
CYMBOPOGON CITRATUS LEAF (UNII: 06JMS448M5)	0.2 mL  in 100 mL

Product Characteristics
Color		Score
Shape		Size
Flavor	LEMON	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54304-074-01	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/25/2020	07/14/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/25/2020	07/14/2020

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

Revised: 7/2020

Document Id: aa77ce96-4f31-5e63-e053-2995a90a8dfd

34390-5

Set id: a7b7fa6b-cc00-14cf-e053-2a95a90a00fa

Version: 3

Effective Time: 20200715