ISLEAF BOTANIC SHIELD FACIAL BARRIER GELCREAM (GLYCERIN) CREAM [C3 CO., LTD.]

ISLEAF BOTANIC SHIELD FACIAL BARRIER GELCREAM (GLYCERIN) CREAM [C3 CO., LTD.]
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NDC 70818-017-01
Set ID 57cb82e7-e58c-4812-e053-2a91aa0a1c0d
Category HUMAN OTC DRUG LABEL
Packager C3 Co., Ltd.
Generic Name
Product Class
Product Number
Application Number PART347
  • ACTIVE INGREDIENT

    glycerin

  • INACTIVE INGREDIENT

    water, propylene glycol, dimethicone, etc

  • PURPOSE

    skin protectant

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children

  • INDICATIONS & USAGE

    Take a pearl-sized amount of FACIAL BARRIER GEL CREAM and gently apply all parts of the face to outside following the skin texture at the last step of the skin care

  • WARNINGS

    1. If the following symptoms occur after product use, stop using the product immediately and consult a dermatologist (continuous use can exacerbate the symptoms).
    1) Occurrence of red spots, swelling, itchiness, and other skin irritation
    2) If the symptoms above occur after the application area is exposed to direct sunlight
    2. Do not use on open wounds, eczema, and other skin irritations
    3. Precaution for Storage and Handling
    1) Close the lid after use
    2) Keep out of reach of infants and children
    3) Do not to store in a place with high/low temperature and exposed to direct sunlight

    4. Use as avoiding eye areas.

  • DOSAGE & ADMINISTRATION

    for external use only

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    ISLEAF BOTANIC SHIELD FACIAL BARRIER GELCREAM 
    glycerin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70818-017
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70818-017-0150 g in 1 CONTAINER; Type 0: Not a Combination Product08/28/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34708/08/2017
    Labeler - C3 Co., Ltd. (689846633)
    Registrant - C3 Co., Ltd. (689846633)
    Establishment
    NameAddressID/FEIBusiness Operations
    C3 Co., Ltd.689846633label(70818-017) , pack(70818-017) , manufacture(70818-017)

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