Label: DERMATITIS FACE BALM- colloidal oatmeal ointment

  • 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 February 3, 2022

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

View All Sections
  • 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

    Petrolatum, Glycine Soja (Soybean) Oil, Butyrospermum Parkii (Shea) Butter, Simmondsia Chinensis (Jojoba) Seed Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Beeswax, Paraffin, Allantoin, Tocopherol.

  • PRINCIPAL DISPLAY PANEL

    61328-121-1261328-121-12

  • INGREDIENTS AND APPEARANCE
    DERMATITIS FACE BALM 
    colloidal oatmeal ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61328-121
    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:61328-121-1213.5 g in 1 TUBE; Type 0: Not a Combination Product02/03/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34702/03/2022
    Labeler - Skinfix, Inc. (203158183)
    Registrant - Skinfix, Inc. (203158183)
    Establishment
    NameAddressID/FEIBusiness Operations
    Canadian Custom Packaging Company207062514manufacture(61328-121)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!