Label: FASCY MOISTURE BOMB HAND CRE AM GRAPEFRUIT- 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 September 29, 2016

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  • 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, Butylene Glycol, Panthenol, Allantoin, 1,2-Hexanediol, Citrus Paradisi (Grapefruit) Fruit Extract, Aloe Barbadensis Leaf Extract, Ethylhexylglycerin, Disodium EDTA, Methylparaben, Propylparaben, Phenoxyethanol, CI 14700, CI 19140, CI 17200, 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 GRAPEFRUIT 
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70991-010
    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:70991-010-021 in 1 CARTON08/01/2016
    1NDC:70991-010-0180 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(70991-010)
    Establishment
    NameAddressID/FEIBusiness Operations
    WELCOS CO.,LTD.689131584manufacture(70991-010)
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