Label: COLLOIDAL OATMEAL cream

  • NDC Code(s): 0869-0965-18, 0869-0965-32, 0869-0965-44, 0869-0965-98
  • Packager: Vi-Jon
  • 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 18, 2020

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

  • claims

    eczema soothing

    moisturizing

    lotion

    skin protectant

  • Active ingredient

    Colloidal oatmeal 1%

  • Purpose

    Skin protectant

  • Uses

    temporarily protects and helps relieve minor skin irritation and itching due to: 

    • eczema
    • rashes
  • 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 withing a few days
  • Keep out of reach of children.

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

  • Directions

    apply as needed

  • Inactive ingredients

    water, glycerin, distearyldimonium chloride, petrolatum, isopropyl palmitate, cetyl alcohol, pathenol, dimethicone, Avena sativa (oat) kernel oil, steareth-20, Avena sativa (oat) kernel extract, benzalkonium chloride, ceramide NP, sodium chloride, benzyl alcohol, sodium hydroxide

  • principal display panel

    mountain falls

    *Compare to Aveeno

    natural

    colloidal

    oatmeal

    soothes dry, itchy, & irritated skin resulting from eczema

    dermatologist tested

    fragrace

    free

    eczema

    soothing

    moisturizing

    lotion

    skin protectant

    NET WT 7.3 OZ (207 g)

    image description

  • principal display panel

    SIMPLY

    U

    ECZEMA

    SOOTHING

    MOSTURIZING

    CREAM

    COLLOIDAL OATMEAL

    SKIN PROTECTANT

    soothes dry, itchy &

    irritated skin resulting

    from eczema

    steroid-free

    fragrance free

    Compare to Aveeno Active Naturals

    Eczema Therapy Moisturizing Cream*

    NET WT 7.3 OZ (207 g)

    image description

  • INGREDIENTS AND APPEARANCE
    COLLOIDAL OATMEAL 
    colloidal oatmeal cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0869-0965
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL10.4 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    OAT KERNEL OIL (UNII: 3UVP41R77R)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    OAT (UNII: Z6J799EAJK)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0869-0965-1871 g in 1 TUBE; Type 0: Not a Combination Product04/22/2014
    2NDC:0869-0965-98207 g in 1 TUBE; Type 0: Not a Combination Product04/22/2014
    3NDC:0869-0965-32340 g in 1 TUBE; Type 0: Not a Combination Product04/22/2014
    4NDC:0869-0965-44510 g in 1 TUBE; Type 0: Not a Combination Product04/22/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34704/22/2014
    Labeler - Vi-Jon (790752542)
    Registrant - Vi-Jon (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon790752542manufacture(0869-0965)