FASCY MOISTURE BOMB HAND CRE AM MILK (DIMETHICONE) CREAM [FASCY CO,.LTD.]

FASCY MOISTURE BOMB HAND CRE AM MILK (DIMETHICONE) CREAM [FASCY CO,.LTD.]
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NDC 70991-040-01, 70991-040-02
Set ID ad2e1000-0405-4650-8499-96a2b22764f9
Category HUMAN OTC DRUG LABEL
Packager FASCY Co,.LTD.
Generic Name
Product Class
Product Number
Application Number PART347
  • ACTIVE INGREDIENT

    Active Ingredient: Dimethicone 1.0%

  • INACTIVE INGREDIENT

    Inactive Ingredients: Water, Glycerin, Cetearyl Alcohol, Mineral Oil, Dipropylene Glycol, Cyclopentasiloxane, Glyceryl Stearate, PEG-100 Stearate, Polysorbate 60, Sorbitan Stearate, Sodium Polyacrylate, Ethylhexyl Stearate, Xanthan Gum, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Adenosine, Potassium Hydroxide, Trideceth-6, Butyrospermum Parkii (Shea) Butter, Panthenol, Butylene Glycol, Allantoin, Milk Protein Extract, 1,2-Hexanediol, Aloe Barbadensis Leaf Extract, Ethylhexylglycerin, Disodium EDTA, Methylparaben, Propylparaben, Phenoxyethanol, Fragrance

  • PURPOSE

    Purpose: Skin Protectant

  • WARNINGS

    Warnings: For external use only. When using this product do not get into eyes, Stop use and ask a doctor if rash occurs. Do not use on - deep puncture wounds - animal bites - serious burns. Keep out of reach of children. Do not keep it in direct sunlight, high or low temperature.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • How to use

    How to use: Apply desired amount and massage into the hands.

  • How to use

    How to use: Apply desired amount and massage into the hands.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    FASCY MOISTURE BOMB HAND CRE AM MILK 
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70991-040
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) Dimethicone0.8 g  in 80 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70991-040-021 in 1 CARTON08/01/2016
    1NDC:70991-040-0180 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34708/01/2016
    Labeler - FASCY Co,.LTD. (689204222)
    Registrant - FASCY Co,.LTD. (689204222)
    Establishment
    NameAddressID/FEIBusiness Operations
    FASCY Co,.LTD.689204222repack(70991-040)
    Establishment
    NameAddressID/FEIBusiness Operations
    WELCOS CO.,LTD.689131584manufacture(70991-040)

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