ROOTREE TREETHERAPY CAMPHORA 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,Cetyl Alcohol,Glycerin,Butylene Glycol,Cetyl Ethylhexanoate,Stearic Acid,Beeswax,Butyrospermum Parkii (Shea) Butter,Helianthus Annuus (Sunflower) Seed Oil,Cinnamomum Camphora (Camphor) Leaf Extract,Chrysanthemum Zawadskii Extract,Sasa Quelpaertensis Extract,Vitex Trifolia Fruit Extract,Benzyl Alcohol,Pyrus Malus (Apple) Fruit Extract,Prunus Serotina (Wild Cherry) Fruit Extract,Ethoxydiglycol,Mangifera Indica (Mango) Seed Butter,Glyceryl Stearate,PEG-100 Stearate,Caprylhydroxamic Acid,Caprylyl Glycol,Arginine,Carbomer,Polysorbate 60,Sorbitan Sesquioleate,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:

Containing the energy of Jeju camphor tree and vegetable butter ingredient, it delivers abundant nutrients. It presents delicate fragrance of jasmine and its soft embracement.

Directions

Directions:

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

ROOTREE TREETHERAPY CAMPHORA HAND RELIEF 
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72441-010
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)  
Cetyl Alcohol (UNII: 936JST6JCN)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72441-010-021 in 1 CARTON07/01/2018
1NDC:72441-010-0130 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(72441-010)

Revised: 7/2018
Document Id: 7f0712a6-a55a-4054-83ec-cb7c48a345ff
Set id: 7c4747b8-1918-4954-a9db-72ee2bd9c427
Version: 1
Effective Time: 20180730
 
KTCS Corporation