DR HYDROCELL PHYTONCIDE CLEAN- alcohol gel
WOOSOR HOLDINGS 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.

----------

ACTIVE INGREDIENT

Active ingredients: ALCOHOL 62.0%

INACTIVE INGREDIENT

Inactive ingredients:

Water, Glycerin, Sodium Hyaluronate, Carbomer, Hinokitiol, Triethanolamine, Flavor

PURPOSE

Purpose: ANTISEPTIC

WARNINGS

Warnings:

For external use only

* Keep away from heat and flame
* Do not use in mouth, ears or eyes.
* When using this product, avoid contact with eyes.
* In case of contact, flush eyes with water.
* Stop use and seek a doctor if redness or irritation develops
* Keep out of reach of children
* Children should be supervised when using this product.
* Store in a cool place.
* keep out of direct sunlight.

KEEP OUT OF REACH OF CHILDREN

Uses

Uses:

Disinfection of hands and skin

Directions

Directions:

Take an appropriate amount on your hands and rub thoroughly to dry.

PACKAGE LABEL - DR. Hydrocell Phytoncide Clean Gel 70mL

Image of carton

PACKAGE LABEL - DR. Hydrocell Phytoncide Clean Gel 500mL

Image of bottle

DR HYDROCELL PHYTONCIDE CLEAN
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:74922-010
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
.BETA.-THUJAPLICIN (UNII: U5335D6EBI)
TROLAMINE (UNII: 9O3K93S3TK)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:74922-010-01	70 mL in 1 CARTON; Type 0: Not a Combination Product	04/01/2020
2	NDC:74922-010-02	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	04/01/2020

Labeler - WOOSOR HOLDINGS CO., LTD (631151946)

Registrant - WOOSOR HOLDINGS CO., LTD (631151946)

Name	Address	ID/FEI	Business Operations
Establishment
GREENWONIL CO., LTD.		688442099	manufacture(74922-010)