GYEOL (DIMETHICONE) SHAMPOO [MAYIMHAYYIM BIO CO., LTD.]

GYEOL (DIMETHICONE) SHAMPOO [MAYIMHAYYIM BIO CO., LTD.]
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NDC 70354-0001-1
Set ID a909801b-87ce-4d43-ad1e-129d6a455761
Category HUMAN OTC DRUG LABEL
Packager MayimHayyim Bio Co., ltd.
Generic Name
Product Class
Product Number
Application Number PART347
  • ACTIVE INGREDIENT

    glycerin


  • INACTIVE INGREDIENT

    water, butylene glycol, etc.


  • PURPOSE

    skin protectant


  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children


  • INDICATIONS & USAGE

    apply maks to lean face
    leave the mask on your face about 20 minutes until it begins to dry


  • WARNINGS

    1. Do not use in the following cases(Eczema and scalp wounds)
    2.Side Effects
    1)Due to the use of this druf if rash, irritation, itching and symptopms of hypersnesitivity occur dicontinue use and consult your phamacisr or doctor
    3.General Precautions
    1)If in contact with the eyes, wash out thoroughty with water If the symptoms are servere, seek medical advice immediately
    2)This product is for exeternal use only. Do not use for internal use
    4.Storage and handling precautions
    1)If possible, avoid direct sunlight and store in cool and area of low humidity
    2)In order to maintain the quality of the product and avoid misuse
    3)Avoid placing the product near fire and store out in reach of children

  • DOSAGE & ADMINISTRATION

    for external use only


  • PRINCIPAL DISPLAY PANEL

    package label
  • INGREDIENTS AND APPEARANCE
    GYEOL 
    dimethicone shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70354-0001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE0.6 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70354-0001-1300 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34712/18/2015
    Labeler - MayimHayyim Bio Co., ltd. (689041078)
    Registrant - MayimHayyim Bio Co., ltd. (689041078)
    Establishment
    NameAddressID/FEIBusiness Operations
    MayimHayyim Bio Co., ltd.689036771manufacture(70354-0001)

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