Label: JENA CELL VL VOLUME LIFT GRAVITY ESSENCE- glycerin liquid

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated June 4, 2018

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  • ACTIVE INGREDIENT

    glycerin

  • INACTIVE INGREDIENT

    water, arginine, carbomer, etc

  • PURPOSE

    skin protectant

  • 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 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 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.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • INDICATIONS & USAGE

    apply proper amount to the skin

  • DOSAGE & ADMINISTRATION

    external use only

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    JENA CELL VL VOLUME LIFT GRAVITY ESSENCE 
    glycerin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72311-0002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN10 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72311-0002-1100 mL in 1 BOTTLE; Type 0: Not a Combination Product06/04/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34706/04/2018
    Labeler - Jena International Ltd (694845597)
    Registrant - Jena International Ltd (694845597)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jena International Ltd694845597manufacture(72311-0002)
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