Label: ROOTREE TREETHERAPY MOBIFERA HAND RELIEF- dimethicone cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated July 30, 2018

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  • ACTIVE INGREDIENT

    Active ingredients: Dimethicone 2.0%

  • INACTIVE INGREDIENT

    Inactive ingredients:

    Water,Butyrospermum Parkii (Shea) Butter,Glycerin,Cetearyl Alcohol,Hyaluronic Acid,Glyceryl Stearate,PEG-100 Stearate,Helianthus Annuus (Sunflower) Seed Oil,Dendropanax Morbifera Extract,Mentha Arvensis Leaf Extract,Brassica Napus Extract,Citrus Sudachi Fruit Juice,Benzyl Alcohol,Butylene Glycol,Milk Protein Extract,Silkworm Cocoon Extract,1,2-Hexanediol,Stearic Acid,Xanthan Gum,Ceteareth-20,Polyacrylamide,C13-14 Isoparaffin,Laureth-7,Fragrance,Disodium EDTA,Phenoxyethanol

  • 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:

    With the vitality of Jeju dendropanax morbifera, this cream presents long-lasting moisturizing effect. It softly absorbs into skin without stickiness and delivers sweet and romantic lilac aroma with refreshing feeling.

  • Directions

    Directions:

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

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    ROOTREE TREETHERAPY MOBIFERA HAND RELIEF 
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72441-020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) Dimethicone0.6 g  in 30 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72441-020-021 in 1 CARTON07/01/2018
    1NDC:72441-020-0130 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(72441-020)
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