Label: NANOMIX BODY CARE- dimethicone lotion

  • 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 August 19, 2013

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredient: Dimethicone 1.2%

  • INACTIVE INGREDIENT

    Inactive Ingredient: Water, Glycerin, Cetyl Ethylhexanoate, Urea, Caprylic/Capric Triglyceride, Pentylene Glycol , Dimethicone, Cetearyl Alcohol, Butyrospermum Parkii (Shea) Butter, Zea Mays (Corn) Starch, Propanediol, Stearic Acid, Glyceryl Stearate, PEG-100 Stearate, Arachidyl Alcohol, Behenyl Alcohol, Olea Europaea (Olive) Fruit Oil, Caprylyl Glycol Fragrance(Parfum), Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Arachidyl Glucoside, Isohexadecane, Arginine, Xanthan Gum, Carbomer, Polysorbate, Colloidal Silver, Serine

  • PURPOSE

    Purpose: Skin Protectant

  • WARNINGS

    Warnings:
    1. In case of having following symptoms after using this, you’re advised to stop using it immediately. If you keep using it, the symptoms will get worse and need to consult a dermatologist.
    1) In case of having problems such as red rash, swollenness, itching, stimulation during usage.
    2) In case of having the same symptoms above on the part you put this product on by direct sunlight.
    2. You are banned to use it on the part where you have a scar, eczema, or dermatitis.
    3. In case of getting it into your eyes, you have to wash it immediately.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children:
    Keep out of reach of babies and children.

  • INDICATIONS AND USAGE

    Indication and usage:
    Avoid to direct sunlight.
    Do not keep in hot(higer 40C) or cold(below 0C).
    Rotate the cap of pump counterclockwise and then rise the cap, press the pump cap to use the lotion.

  • DOSAGE AND ADMINISTRATION

    Dosage and administration:
    Apply after washing body.
    Take a small amount of lotion about 2g onto the fingertips and gently massage over the entire body.
    Especially use the lotion over dry or itchy part 2-3 times per day.

  • PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    NANOMIX BODY CARE 
    dimethicone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54170-110
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) Dimethicone4.8 mg  in 400 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54170-110-01400 mL in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34706/01/2013
    Labeler - NANOPOLY CO., LTD. (687162537)
    Registrant - NANOPOLY CO., LTD. (687162537)
    Establishment
    NameAddressID/FEIBusiness Operations
    NANOPOLY CO., LTD.687162537repack(54170-110)
    Establishment
    NameAddressID/FEIBusiness Operations
    COSMAX INC.689019313manufacture(54170-110)