Label: HAISHEN 80 SEA CUCUMBER NUTRITIVE FRESH- 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 April 8, 2016

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

  • ACTIVE INGREDIENT

    Active Ingredient: DIMETHICONE 1.0%

  • INACTIVE INGREDIENT

    Inactive Ingredients: SEA CUCUMBER EXTRACT, WATER, CYCLOPENTASILOXANE, DIPROPYLENE GLYCOL, GLYCERETH-26, NIACINAMIDE, GLYCERIN, HYDROXYPROPYL STARCH PHOSPHATE, GLYCERYL CAPRYLATE, SWIFTLET NEST EXTRACT, CYCLOHEXASILOXANE, CARBOMER, TRIETHANOLAMINE, DIMETHICONOL, GLYCERYL STEARATE, CHLORPHENESIN, PEG-150 DISTEARATE, PERFUME, BUTYLENE GLYCOL, GLYCERYL POLYACRYLATE, POLYSORBATE 80, VP/EICOSENE COPOLYMER, CETEARYL ALCOHOL, PHENOXYETHANOL, ETHYLHEXYLGLYCERIN, ADENOSINE, DISODIUM EDTA, SODIUM HYALURONATE, ALLANTOIN, CAVIAR EXTRACT

  • PURPOSE

    Purpose: Skin Protectant

  • WARNINGS

    Warnings: 1. If the following side effects occur, immediately discontinue use. Before resuming use, consult a dermatologist as continual use may worsen symptoms. A) If red spots, swelling, itching, irritation, or other discomforts occur after using the product. B) If the above symptoms occur on the applied area after exposure to direct sunlight. 2. Do not use on open wounds or on areas of skin exhibiting signs of eczema or dermatitis. 3. Storage and handling precautions A) Keep product out of reach of infants and children. B) Ensure that lid is closed after use. C) Do not store in places subject to high or cold temperatures or under exposure to direct sunlight. D) Use care to avoid eye contact when using this product.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • INDICATIONS & USAGE

    Indications & usage: Apply smoothly on the entire face in the morning and night.

  • DOSAGE & ADMINISTRATION

    Dosage & Administration: Take an adequate amount of this product.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    HAISHEN 80 SEA CUCUMBER NUTRITIVE FRESH 
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70603-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE0.8 g  in 80 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70603-010-021 in 1 CARTON03/02/2016
    1NDC:70603-010-0180 g in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/02/2016
    Labeler - JUNGLEFOOD CO., LTD. (689605638)
    Registrant - JUNGLEFOOD CO., LTD. (689605638)
    Establishment
    NameAddressID/FEIBusiness Operations
    JUNGLEFOOD CO., LTD.689605638manufacture(70603-010)