TRUEZYME BABY SHAMPOOANDBODY WASH (GLYCERIN) LIQUID [TRUEZYME CO., LTD.]

TRUEZYME BABY SHAMPOOANDBODY WASH (GLYCERIN) LIQUID [TRUEZYME CO., LTD.]
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NDC 71076-0002-1
Set ID 41652c38-145f-062b-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager Truezyme Co., Ltd.
Generic Name
Product Class
Product Number
Application Number
  • ACTIVE INGREDIENT

    Glycerin

  • PURPOSE

    Cleanse, moisturize, and smoothen sensitive baby's skin gently.

  • INACTIVE INGREDIENT

    Sea Water, Water, Lauryl Glucoside, Decyl Glucoside, Pentylene Glycol, Laminaria Japonica Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Butylene Glycol, Panthenol, etc.

  • WARNINGS

    1. Stop using the product if there are any of the following abnormal symptoms appearing after use and consult with your dermatologist as continued use can worsen the symptoms.

    1) If there are red spots, swelling, itchiness, or irritation

    2) If the above symptoms appear around the skin to which the product has been applied after being exposed to direct sunlight.

    2. Do not apply the product to any parts of the skin with wound, eczema, or dermatitis.

    3. If it gets into eye, wash the eye with clean water immediately.

    4. Wash away with water enough after use since not enough rinsing can lead to hair loss or discoloration.

    5. Those who are allergic to certain medicinal herb, such as pollen and tangerine, must stop using the product if they experience hypersensitivity. 6. Precautions on storage and handling

    1) Make sure to close the cap after use.

    2) Keep out of the reach of children.

    3) Do not keep the product in a hot or cold place or a place getting direct sunlight.

  • INDICATIONS & USAGE

    - Wet the whole body and lather well on a shower sponge, a towel, or hands and massage the whole body gently and wash away with water cleanly.

    - For a bath, you can enjoy a refreshing enzymatic bath by lathering enough in warm water.

    * Shake well before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

    For the external use only

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    TRUEZYME BABY SHAMPOOANDBODY WASH 
    glycerin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71076-0002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN3.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71076-0002-1300 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/01/2016
    Labeler - Truezyme Co., Ltd. (693938262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Truezyme Co., Ltd.693938262manufacture(71076-0002)

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