Label: WHITE MALLOW DIAPER RASH CREAM- zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 August 22, 2014

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

  • PRINCIPAL DISPLAY PANEL

    Weleda

    Since 1921

    Baby Derma

    White Mallow

    Diaper Rash Cream

    Relieves and protects

    Sensitive Skin - Fragrance free

    Mauve Blanche

    Crème contre l`Erythème Fessier

    Soulage et protège

    Peau sensible - Sans parfum

    Certified Natural Baby Care      

    Le Soin Naturel Authentique

    NPN 80044523

    NET WT / POIDS NET 1.9 OZ (55.1g)

    LARGE BOXLEAFLET PAGE 1LEAFLET PAGE 2LARGE TUBE

  • ACTIVE INGREDIENT

    Active ingredient

    Zinc Oxide 14%

  • 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

    Temporarily helps to relieve minor skin irritations due to diaper rash.

    Protects chafed skin from minor skin irritations, for sensitive skin.

    Helps protect from wetness that causes diaper rash.

  • 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.

    Use after each diaper change until skin irritation heals, or as directed by a physician.

  • INACTIVE INGREDIENT

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

    Borage Oil, Coconut Oil, Glyceryl Caprylate, Glyceryl Oleate, Glycerin, Hydrolyzed Beeswax, Lactic Acid, Lanolin, Sesame Seed Oil, Sodium Caproyl Lactylate, Sodium Lauroyl Lactylate, Sunflower Oil Unsaponifiables, Sweet Almond Oil, Viola tricolor Extract, Water, White Mallow (Althaea officinalis) Root Extract, White Wax.

  • PRINCIPAL DISPLAY PANEL

    Weleda

    Since 1921

    Baby Derma

    White Mallow

    Diaper Rash Cream

    Sensitive Skin - Fragrance free

    Mauve Blanche

    Crème contre l'Erythème Fessier

    Peau sensible - Sans parfum

    Certified Natural Baby Care

    Le Soin Naturel Authentique

    NET WT / POIDS NET 0.1 OZ (3g)

    SACHET

  • INGREDIENTS AND APPEARANCE
    WHITE MALLOW DIAPER RASH CREAM 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0164-2207
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE14 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    BORAGE OIL (UNII: F8XAG1755S)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    GLYCERYL OLEATE (UNII: 4PC054V79P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    LANOLIN (UNII: 7EV65EAW6H)  
    SESAME OIL (UNII: QX10HYY4QV)  
    SODIUM CAPROYL LACTYLATE (UNII: 87WR3BHC09)  
    SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    VIOLA TRICOLOR (UNII: 9Q24RAI43V)  
    WATER (UNII: 059QF0KO0R)  
    ALTHAEA OFFICINALIS ROOT (UNII: TRW2FUF47H)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0164-2207-6555.1 g in 1 TUBE
    2NDC:0164-2207-663 g in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34708/22/2014
    Labeler - Weleda A.G. Schwäbisch Gmünd, Zweigniederlassung der Weled (315541862)
    Establishment
    NameAddressID/FEIBusiness Operations
    Weleda A.G. Schwäbisch Gmünd, Zweigniederlassung der Weled315541862manufacture(0164-2207)