Label: VITALISING TONIC- glycerin lotion

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

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Drug Label Information

Updated March 21, 2017

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  • ACTIVE INGREDIENT

    Active ingredients: GLYCERIN 4.6%

  • INACTIVE INGREDIENT

    Inactive ingredients: AQUA (WATER), PROPANEDIOL, PEG-40 HYDROGENATED CASTOR OIL, CENTAUREA CYANUS FLOWER WATER, SODIUM ANISATE, SODIUM LEVULINATE, POLYQUATERNIUM-11, PARFUM (FRAGRANCE), SODIUM BENZOATE, OENOTHERA BIENNIS (EVENING PRIMROSE) LEAF EXTRACT, CI 14700 (FD&C RED N°4)

  • PURPOSE

    Purpose: Skin hydrating and smoothing

  • 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: Use twice daily

  • DOSAGE & ADMINISTRATION

    Dosage & Administration: Apply it to your face neck, and decolletage with cotton pads

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    VITALISING TONIC 
    glycerin lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71276-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN8.28 g  in 180 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71276-010-021 in 1 CARTON03/02/2017
    1NDC:71276-010-01180 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(71276-010)
    Establishment
    NameAddressID/FEIBusiness Operations
    U-LAB Switzerland AG485958743manufacture(71276-010)
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