Label: BABY ECZEMA THERAPY- 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 September 13, 2022

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  • Active ingredients

    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 within 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

  • Other information

    store at room temperature

  • Inactive ingredients

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

  • disclaimer

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

  • Adverse Reactions

    DISTRIBUTED BY OLD EAST MAIN CO

    100% Satisfaction

    Guaranteed!

  • principal display panel

    DG baby

    Baby Eczema Therapy Cream

    Colloidal Oatmeal Skin Protectant

    Compare to Aveeno

    Baby Eczema Therapy Moisturizing Cream

    • Helps reduces itching and irritation associated with eczema
    • Steroid Free
    • Fragrance Free

    NET WT 5 OZ (141g)

    image description

  • principal display panel

    *Compare to Aveeno Baby Eczema Therapy Moisturizing Cream

    Gentle Steps

    baby

    eczema

    therapy

    cream

    Colloidal Oatmeal Skin Protectant

    Steroid & Fragrance Free

    Helps to reduce itching and irritation associated with eczema

    NET WT 5 OZ (141)

    image description

  • INGREDIENTS AND APPEARANCE
    BABY ECZEMA THERAPY 
    colloidal oatmeal cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-803
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    oatmeal (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) oatmeal10.4 kg  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)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    CERAMIDE NP (UNII: 4370DF050B)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55910-803-28141 g in 1 TUBE; Type 0: Not a Combination Product04/11/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34704/11/2016
    Labeler - OLD EAST MAIN CO. (068331990)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(55910-803)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(55910-803)
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