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CALENDULA DIAPER RASH CREAM (Weleda A.G. Schwabisch Gmund, Zweigniederlassung der Weled)

Available Formats

Dosage Form Package Information Links
CREAM 10.8 g in 1 TUBE (0164-2189-54) Label Information
CREAM 81 g in 1 TUBE (0164-2189-53) Label Information
CREAM 1.5 g in 1 POUCH (0164-2189-49) Label Information

Complete CALENDULA DIAPER RASH CREAM Information

  • 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 Type HUMAN OTC DRUG Item Code (Source) NDC:0164-2189
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 12 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0164-2189-53 81 g in 1 TUBE
    2 NDC:0164-2189-54 10.8 g in 1 TUBE
    3 NDC:0164-2189-49 1.5 g in 1 POUCH
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part347 06/27/2013
    Labeler - Weleda A.G. Schwäbisch Gmünd, Zweigniederlassung der Weled (315541862)
    Establishment
    Name Address ID/FEI Business Operations
    Weleda A.G. Schwäbisch Gmünd, Zweigniederlassung der Weled 315541862 manufacture(0164-2189)