Label: DERMATITIS FACE BALM- colloidal oatmeal ointment

  • NDC Code(s): 54291-040-01, 54291-040-02
  • Packager: Canadian Custom Packaging Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 11, 2024

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  • Active Ingredients

    Colloidal Oatmeal 5%

  • Purpose

    Skin protectant

  • Uses

    Temporarily protects and helps relieve minor skin irritations and itching due to eczema, rash and dermatitis.

  • Warnings

    For external use only.

    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.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.

  • Directions

    Apply to affected areas as needed.

  • OTHER INFORMATION

    STORE AT 65-75°F. MAY STAIN FABRICS. FOR ADULTS AND CHILDREN TWO YEARS OF AGE AND OLDER.

  • Inactive Ingredients

    Allantoin, Beeswax, butyrospermum parkii (shea) butter, glycine soja (soybean) oil, paraffin wax, petrolatum, prunus amygdalus dulcis (sweet almond) oil, simmondsia chinensis (jojoba) seed oil, tocopherol.

  • PRINCIPAL DISPLAY PANEL

    Skinfix_.48oz_US_Face_Balm_D16983A_V9_R - box.jpg

  • INGREDIENTS AND APPEARANCE
    DERMATITIS FACE BALM 
    colloidal oatmeal ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54291-040
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALLANTOIN (UNII: 344S277G0Z)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    JOJOBA OIL (UNII: 724GKU717M)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54291-040-0160 g in 1 TUBE; Type 0: Not a Combination Product12/26/2018
    2NDC:54291-040-0213.5 g in 1 TUBE; Type 0: Not a Combination Product12/26/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01612/26/2018
    Labeler - Canadian Custom Packaging Company (207062514)
    Registrant - Canadian Custom Packaging Company (207062514)
    Establishment
    NameAddressID/FEIBusiness Operations
    Canadian Custom Packaging Company207062514manufacture(54291-040)
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