Label: JENA CELL VL GRAVITY ESSENCE FOR BODY ONLY.- glycerin liquid

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

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated May 20, 2018

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  • ACTIVE INGREDIENT

    glycerin

  • INACTIVE INGREDIENT

    water, hydrogenated polyisobutene, arginine, etc

  • PURPOSE

    skin protectant

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children

  • INDICATIONS & USAGE

    apply proper amount to the skin

  • WARNINGS

    ■store between 20-25 °C (68-77 °F)
    ■avoid freezing and excessive heat above 40 °C (104 °F)

  • DOSAGE & ADMINISTRATION

    keep out of eyes, ears and mouth, If contact occurs, rinse with plenty of worm or cold water right away and in a serious situation, contact a physician. If swallowing, drink plenty of water and contact a physician

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    JENA CELL VL GRAVITY ESSENCE FOR BODY ONLY. 
    glycerin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72311-0001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN0.3 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ARGININE (UNII: 94ZLA3W45F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72311-0001-1100 mL in 1 BOTTLE; Type 0: Not a Combination Product05/21/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/21/2018
    Labeler - Jena International Ltd (694845597)
    Registrant - Jena International Ltd (694845597)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jena International Ltd694845597manufacture(72311-0001)