Label: WALGREENS ECZEMA RELIEF BODY SKIN PROTECTANT- 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 December 5, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Colloidal oatmeal 1.0%

  • 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 avoid contact with 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 or as directed by a doctor. For children under 3 months of age: Ask a doctor.

  • Other information

    For mild to moderate eczema. Store at room temperature.

  • Inactive ingredients

    water, glycerin, cetyl alcohol, mineral oil, glyceryl stearate SE, caprilic/capric triglyceride, cetyl palmitate, ricinus communis (castor) seed oil, PEG-40 stearate, octyldodecanol, steareth-21, glycyrrhiza inflate root extract, ceramide NP, phenoxyethanol, ethylhexylglycerin, benzyl alcohol, citric acid.

  • Questions or comments?

    1-800-925-4733

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY: WALGREEN CO.
    200 WILMOT RD., DEERFIELD, IL 60015

  • PRINCIPAL DISPLAY PANEL - 226 g Tube Label

    Walgreens

    •Walgreens•
    PHARMACIST RECOMMENDED†

    Compare to the active ingredient in
    Eucerin® Eczema Relief Body Cream††

    Eczema
    Relief
    Body
    Cream

    COLLOIDAL OATMEAL 1% /
    SKIN PROTECTANT

    Fragrance Free

    Steroid Free

    • Relieves minor irritation
      & dryness due to eczema
    • Enriched with ceramide NP
      & licorice root extract

    NET WT 8 OZ (226 g)

    PRINCIPAL DISPLAY PANEL - 226 g Tube Label
  • INGREDIENTS AND APPEARANCE
    WALGREENS ECZEMA RELIEF BODY   SKIN PROTECTANT
    oatmeal cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-8395
    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)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    Mineral Oil (UNII: T5L8T28FGP)  
    Glyceryl Stearate SE (UNII: FCZ5MH785I)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    Cetyl Palmitate (UNII: 5ZA2S6B08X)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    PEG-40 STEARATE (UNII: ECU18C66Q7)  
    Octyldodecanol (UNII: 461N1O614Y)  
    Steareth-21 (UNII: 53J3F32P58)  
    GLYCYRRHIZA INFLATA ROOT (UNII: 1MV1Z7MKVQ)  
    Ceramide NP (UNII: 4370DF050B)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Benzyl Alcohol (UNII: LKG8494WBH)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-8395-01226 g in 1 TUBE; Type 0: Not a Combination Product08/06/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34708/06/2021
    Labeler - Walgreen Company (008965063)
    Registrant - Garcoa, Inc. (036464697)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sigan Industries INC.255106239MANUFACTURE(0363-8395)
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