Label: ZINC OXIDE 40%- diaper rash skin 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 September 20, 2022

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  • Active Ingredient

    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.
    • symptoms last more than 7 days or clear up and occur again within a few days

    If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

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

    • See box for more details
  • Inactive Ingredients

    Sunflower oil, Castor Oil, Sunflower seed wax, polyhydroxystearic acid, shea butter, coconut oil, theobroma cacao seed butter, calophyllum seed oil, tocopherol, zea mays corn starch

  • Questions and comments?

    1-888-880-6888

  • Label

    1

  • INGREDIENTS AND APPEARANCE
    ZINC OXIDE 40% 
    diaper rash skin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50157-477
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE40 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    COCONUT OIL (UNII: Q9L0O73W7L)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    CALOPHYLLUM TACAMAHACA SEED OIL (UNII: 05G85L61OE)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50157-477-18118 mL in 1 TUBE; Type 0: Not a Combination Product09/20/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM01609/20/2022
    Labeler - BRANDS INTERNATIONAL (243748238)
    Establishment
    NameAddressID/FEIBusiness Operations
    BRANDS INTERNATIONAL243748238manufacture(50157-477)
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