Label: SOOTHING MOISTURIZING- colloidal oatmeal 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 February 14, 2023

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  • Active ingredient

    Colloidal oatmeal 1 %

  • Purpose

    Skin protectant

  • Uses

    temporarily protectes 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, panthenol, dimethicone, Avena sativa (oat) kernel oil, steareth-20, Avena sativa (oat) kernel extract, benzalkonium chloride, ceramide NP, Butyrospermum parkii (shea) butter, tocopheryl acetate, Eucalyptus globulus leaf oil, sodium chloride, benzyl alcohol, sodium hydroxide

  • Questions?

    1-888-287-1915

    Satisfaction guaranteed - For questions or comments please call 1-888-287-1915

  • SPL UNCLASSIFIED SECTION

    *This product is not manufactured or distributed by Johnson & Johnson Consumer Products Company, distributor of Aveeno Active Naturals Eczema Therapy Moisturizing Cream

    Distributed by Walgreen Co., 200 Wilmot Rd., Deerfield, IL 600015

    walgreens.com (c) 2017 Walgreen Co.

    965.000/965AB

  • principal display panel

    Walgreens

    Eczema Lotion Colloidal Oatmeal 1%/ Skin Protectant

    +vitamin E

    Fragrance free

    with eucalyptus oil

    helps to relieve dry, itchy skin due to eczema

    not made with steroids, parabens, sulfates or phthalates

    Soothes, dry, itchy & irritated skin resulting from eczema

    NET WT 8 OZ (226 g)

    image description

  • INGREDIENTS AND APPEARANCE
    SOOTHING MOISTURIZING 
    colloidal oatmeal cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-9263
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL10 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)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-9263-98226 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 - WALGREENS CO. (008965063)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(0363-9263)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(0363-9263)
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