Label: CALENDULA DIAPER RASH CREAM- zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated June 27, 2013

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  • PRINCIPAL DISPLAY PANEL

    Weleda

    Since 1921

    Baby & Child

    Calendula

    Diaper Rash Cream

    Relieves and protects

    Crème contre l`Erythème Fessier

    Soulage et protège                   

    Certified Natural Baby Care      

    Le Soin Naturel Authentique

    NPN 80005250

    NET WT / POIDS NET 2.8 OZ (81g)

    LARGE TUBEPACKAGE INSERT PAGE 2PACKAGE INSERT PAGE 1LARGE BOX

  • ACTIVE INGREDIENT

    Active ingredient

    Zinc Oxide 12%

  • PURPOSE

    Purpose

    Diaper Rash Cream

  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all medicines out of the reach of children.

  • INDICATIONS & USAGE

    Uses

    Offers temporary, quick and effective relief for minor skin irritations due to diaper rash.

    Minor skin irritations.

    Reliable protection from dampness.

  • WARNINGS

    Warnings

    External use only.

    Avoid contact with eyes.

    Keep this and all medicines out of the reach of children.

  • DOSAGE & ADMINISTRATION

    Directions

    Cleanse area, pat dry, then apply a thin layer of cream.

    Apply to the whole diaper area after careful cleaning.

  • INACTIVE INGREDIENT

    Inactive Ingredients (USA) / Non-Medicinal Ingredients (Canada):

    Beeswax, Calendula Flower Extract, Cananga Oil, Chamomile Flower Extract, Citrus Aurantium Leafy Twig (Petitgrain) Oil, Clary Sage Oil, Glyceryl Linoleate, Hectorite, Lanolin, Lavender Oil, Orange Oil, Rosemary Oil, Sage Oil, Sesame Seed Oil, Styrax Benzoin Resin, Sweet Almond Oil, Water.

  • PRINCIPAL DISPLAY PANEL

    Weleda

    Since 1921

    Baby & Child

    Calendula

    Diaper Rash Cream

    Relieves and protects

    Crème contre l'Erythème Fessier

    Soulage et protège

    Certified Natural Baby Care

    Le Soin Naturel Authentique

    NPN 80005250

    NET WT / POIDS NET 0.4 OZ (10.8g)

    MINI TUBE

    MINI BOX

  • PRINCIPAL DISPLAY PANEL

    Weleda

    Since 1921

    Baby & Child

    Calendula

    Diaper Rash Cream

    Crème contre l'Erythème Fessier

    Certified Natural Baby Care

    Le Soin Naturel Authentique

    NET WT / POIDS NET 0.05 OZ (1.5g)

    SACHET

  • INGREDIENTS AND APPEARANCE
    CALENDULA DIAPER RASH CREAM 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0164-2189
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE12 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    CANANGA OIL (UNII: 8YOY78GNNX)  
    CHAMOMILE (UNII: FGL3685T2X)  
    CITRUS AURANTIUM LEAFY TWIG OIL (UNII: 5K6H1IMT3D)  
    CLARY SAGE OIL (UNII: 87L0D4U3M0)  
    GLYCERYL MONOLINOLEATE (UNII: 4763AXI84L)  
    HECTORITE (UNII: 08X4KI73EZ)  
    LANOLIN (UNII: 7EV65EAW6H)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    SAGE OIL (UNII: U27K0H1H2O)  
    SESAME OIL (UNII: QX10HYY4QV)  
    STYRAX BENZOIN RESIN (UNII: FE663Z8IRO)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0164-2189-5381 g in 1 TUBE
    2NDC:0164-2189-5410.8 g in 1 TUBE
    3NDC:0164-2189-491.5 g in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34706/27/2013
    Labeler - Weleda A.G. Schwäbisch Gmünd, Zweigniederlassung der Weled (315541862)
    Establishment
    NameAddressID/FEIBusiness Operations
    Weleda A.G. Schwäbisch Gmünd, Zweigniederlassung der Weled315541862manufacture(0164-2189)