ROOTREE TREETHERAPY CRYPTOMERIA HAND RELIEF- dimethicone cream 
KTCS Corporation

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

Active ingredients: Dimethicone 1.0%

INACTIVE INGREDIENT

Inactive ingredients:

Water,Glycerin,Butylene Glycol,Cetearyl Alcohol,Ethylhexyl Stearate,Butyrospermum Parkii (Shea) Butter,Stearic Acid,Glyceryl Stearate SE,Glyceryl Stearate,PEG-100 Stearate,Caprylhydroxamic Acid,Caprylyl Glycol,Hyaluronic Acid,Cryptomeria Japonica Leaf Extract,Chamaecyparis Obtusa Leaf Extract,Brassica Napus Extract,Mentha Arvensis Leaf Extract,Triticum Vulgare (Wheat) Sprout Extract,1,2-Hexanediol,Olea Europaea (Olive) Fruit Oil,Helianthus Annuus (Sunflower) Seed Oil,Macadamia Ternifolia Seed Oil,Benzyl Alcohol,Fragrance,Disodium EDTA

PURPOSE

Purpose: Skin Protectant

WARNINGS

Warnings:

For external use only.

Avoid contact with eyes.

Discontinue use if signs of irritation or rashes appear.

Replace the cap after use.

Keep out of reach of children

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

Uses

Uses:

It is a hand cream full of Jeju cryptomeria japonica’s refreshment. It rapidly absorbs into skin with refreshing texture and delicate floral aroma.

Directions

Directions:

After washing hands, apply adequte amount onto skin with soft massage.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

ROOTREE TREETHERAPY CRYPTOMERIA HAND RELIEF 
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72441-030
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) Dimethicone0.3 g  in 30 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Glycerin (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72441-030-021 in 1 CARTON07/01/2018
1NDC:72441-030-0130 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34707/01/2018
Labeler - KTCS Corporation (688326214)
Registrant - KTCS Corporation (688326214)
Establishment
NameAddressID/FEIBusiness Operations
ATEC Co., Ltd.689276681manufacture(72441-030)

Revised: 7/2018
Document Id: db599ba6-7777-476e-8dc7-bfd74e9e6ed4
Set id: 537053dd-b440-425e-a740-857e7ec0d435
Version: 1
Effective Time: 20180730
 
KTCS Corporation