Label: HYALURON 3S SERUM- hyaluronic acid cream

  • 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 March 22, 2017

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  • ACTIVE INGREDIENT

    Active ingredients: HYALURONIC ACID 0.30%

  • INACTIVE INGREDIENT

    Inactive ingredients: AQUA (WATER), GLYCERIN, PEG-8, SACCHAROMYCES/XYLINUM/BLACK TEA FERMENT, PENTYLENE GLYCOL, PHENOXYETHANOL, SODIUM HYALURONATE, GLYCERYL ACRYLATE/ACRYLIC ACID COPOLYMER, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, PPG-26-BUTETH-26, CASSIA ANGUSTIFOLIA SEED POLYSACCHARIDE, DISODIUM EDTA, PARFUM (FRAGRANCE), PEG-40 HYDROGENATED CASTOR OIL, SODIUM HYDROXIDE, o-CYMEN-5-OL, POTASSIUM SORBATE, SODIUM BENZOATE

  • PURPOSE

    Purpose: Skin hydrating and moisturizing

  • WARNINGS

    Warnings: For external use only Avoid contact with eyes. Discontinue use if signs of irritation or rashes appear.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • INDICATIONS & USAGE

    Indications & Usage: Apply morning and night

  • DOSAGE & ADMINISTRATION

    Dosage & Administration: Apply morning and night on clean face and neck prior to moisturizers

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    HYALURON 3S SERUM 
    hyaluronic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71276-140
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYALURONIC ACID (UNII: S270N0TRQY) (HYALURONIC ACID - UNII:S270N0TRQY) HYALURONIC ACID0.15 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71276-140-021 in 1 CARTON03/02/2017
    1NDC:71276-140-0150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/02/2017
    Labeler - ULAB (688976692)
    Registrant - ULAB (688976692)
    Establishment
    NameAddressID/FEIBusiness Operations
    ULAB688976692relabel(71276-140)
    Establishment
    NameAddressID/FEIBusiness Operations
    U-LAB Switzerland AG485958743manufacture(71276-140)