Label: SHYNOMORE LUBRICANT- centella asiatica extract gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated February 1, 2018

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  • ACTIVE INGREDIENT

    Centella Asiatica Extract

  • INACTIVE INGREDIENT

    Sodium Hyaluronate, Hamamelis Virginiana (Witch Hazel) Leaf Extract, etc.

  • PURPOSE

    Water-soluble massage gel

  • KEEP OUT OF REACH OF CHILDREN

    keep out or reach of the children

  • INDICATIONS & USAGE

    With clean hands, dispense an appropriate amount and apply on skin, massaging gently

  • WARNINGS

    Precautions for Use

    If any of the following conditions occur, discontinue use immediately and consult a dermatologist. Continuous use will cause symptoms to worsen.

    1) In case of skin reaction such as red spots, swelling, itch or irritation etc. during use

    2) In case of the above skin reaction when applied area is exposed to direct sunlight

    Do not use on damaged skin area such as wound, rash or skin infection

    Storage and Handling

    1) Close lid tightly after use

    2) Keep out of reach of infants and children

    3) Store in a cool, dry place away from direct sunlight

    4) Avoid eye area

  • DOSAGE & ADMINISTRATION

    for external use only


  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    SHYNOMORE LUBRICANT 
    centella asiatica extract gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72072-0001
    Route of AdministrationVAGINAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CENTELLA ASIATICA (UNII: 7M867G6T1U) (CENTELLA ASIATICA - UNII:7M867G6T1U) CENTELLA ASIATICA15 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72072-0001-1100 mL in 1 TUBE; Type 0: Not a Combination Product01/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/01/2018
    Labeler - Bluette Co., Ltd. (694855403)
    Registrant - Bluette Co., Ltd. (694855403)
    Establishment
    NameAddressID/FEIBusiness Operations
    Daeduck Lab. Co.,Ltd.557819376manufacture(72072-0001)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bluette Co., Ltd.694855403label(72072-0001)