Label: DIAPER RASH CREAM- zinc oxide cream

  • NDC Code(s): 73418-300-04, 73418-300-08
  • Packager: Hello Bello
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 13, 2023

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  • Drug Facts

  • Active Ingredients

    Zinc Oxide - 40%

  • Purpose

    Skin Protectant

  • Uses

    • Helps treat and prevent diaper rash
    • Protects chafed skin due to diaper rash and helps seal out wetness
  • Warnings

    For external use only

    When using this product,

    do not get into eyes

    Stop use and ask a doctor

    if condition worsens or symptoms last more than 7 days or clear up and occur again within a few days

    Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away

  • Directions

    • Change wet and soiled diapers promptly.
    • Cleanse the diaper area and allow to dry.
    • Apply cream liberally as often as necessary, with each diaper change, and especially at bedtime or anytime when exposure to wet diapers may be prolonged
  • Other Information

    • Do not use if quality seal is broken
    • Do not store above 40C (104F)
  • Inactive Ingredients

    Helianthus Annus (Sunflower) Seed Oil*, Ricinus Communis (Castor) Seed Oil*, Butyrospermum Parkii (Shea) Butter*, Polyhydroxystearic Acid, Helianthus Anuus (Sunflower) Seed Wax*, Cocos Nucifera (Coconut) Oil*, Theobroma Cacao (Cocoa) Seed Butter*, Colophyllum Tacamahaca Seed Oil*, Tocopherol*, Zea Mays (Corn) Starch*

    *Organic

  • PRINCIPAL DISPLAY PANEL

    HelloBello-dieline-DiaperRashCream-4oz-box-Jan2023_AOHelloBello-dieline-DiaperRashCream-4oz-US_Jan2023_AO

  • INGREDIENTS AND APPEARANCE
    DIAPER RASH CREAM 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73418-300
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE400 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CALOPHYLLUM TACAMAHACA SEED OIL (UNII: 05G85L61OE)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73418-300-081 in 1 CARTON10/13/2023
    1NDC:73418-300-04113 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01610/13/2023
    Labeler - Hello Bello (081135707)
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