Label: CELLBN FIRST CARE CLEANSER- stearic acid cream

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

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Drug Label Information

Updated May 29, 2017

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  • ACTIVE INGREDIENT

    Stearic Acid

  • INACTIVE INGREDIENT

    Water, Butylene Glycol, Etc

  • PURPOSE

    Skin Protectant - Cleasing

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of the children

  • INDICATIONS & USAGE

    1. Wet the face with warm water.
    2. Apply to the face and around the neck with gently massaging action for abount 1~2 minutes.
    3. Rinse thoroughly with warm water.
  • 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
    CELLBN FIRST CARE CLEANSER 
    stearic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71450-0006
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    STEARIC ACID (UNII: 4ELV7Z65AP) (STEARIC ACID - UNII:4ELV7Z65AP) STEARIC ACID16 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71450-0006-1130 mL in 1 TUBE; Type 0: Not a Combination Product05/26/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/26/2017
    Labeler - WORLDCOSTEC.CO.,LTD (688297917)
    Registrant - WORLDCOSTEC.CO.,LTD (688297917)
    Establishment
    NameAddressID/FEIBusiness Operations
    WORLDCOSTEC.CO.,LTD688297917manufacture(71450-0006) , label(71450-0006) , pack(71450-0006)
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