Label: CALENDULA DIAPER RASH CREAM- zinc oxide cream

  • NDC Code(s): 55946-701-49, 55946-701-53, 55946-701-54
  • Packager: Weleda, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 07/13

If you are a consumer or patient please visit this version.

  • 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

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  • ACTIVE INGREDIENT

    Active ingredient

    Zinc Oxide 12%

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  • PURPOSE

    Purpose

    Diaper Rash Cream

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  • KEEP OUT OF REACH OF CHILDREN

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

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  • INDICATIONS & USAGE

    Uses

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

    Minor skin irritations.

    Reliable protection from dampness.

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  • WARNINGS

    Warnings

    External use only.

    Avoid contact with eyes.

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

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  • DOSAGE & ADMINISTRATION

    Directions

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

    Apply to the whole diaper area after careful cleaning.

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  • 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.

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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 0.4 OZ (10.8g)

    MINI TUBE

    MINI BOX

    Close
  • 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

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  • INGREDIENTS AND APPEARANCE
    CALENDULA DIAPER RASH CREAM 
    zinc oxide cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:55946-701
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 12 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    YELLOW WAX  
    CALENDULA OFFICINALIS FLOWER  
    CANANGA OIL  
    CHAMOMILE  
    CITRUS AURANTIUM LEAFY TWIG OIL  
    CLARY SAGE OIL  
    GLYCERYL MONOLINOLEATE  
    HECTORITE  
    LANOLIN  
    LAVENDER OIL  
    ORANGE OIL  
    ROSEMARY OIL  
    SAGE OIL  
    SESAME OIL  
    STYRAX BENZOIN RESIN  
    ALMOND OIL  
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55946-701-53 81 g in 1 TUBE
    2 NDC:55946-701-54 10.8 g in 1 TUBE
    3 NDC:55946-701-49 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 07/16/2013
    Labeler - Weleda, Inc. (012301297)
    Registrant - Weleda, Inc. (012301297)
    Establishment
    Name Address ID/FEI Business Operations
    Weleda A.G. Schwäbisch Gmünd, Zweigniederlassung der Weled 315541862 manufacture(55946-701)
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