Label: ECZEMA RELIEF CREAM- colloidal oatmeal cream

  • NDC Code(s): 71521-025-15, 71521-025-50
  • Packager: Lavior Inc
  • 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 March 16, 2022

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  • Active Ingredient

    Colloidal Oatmeal 1%...............................Skin Protectant

  • Purpose

    Skin Protectant

  • Uses

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

    • rashes
    • eczema
  • 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

  • Inactive ingredients

    Water/Aqua/Eau, Glyverin, Inula Viscosa Flower/Leaf/Stem Extract, Xanthan Gum, Glyceryl Stearate Citrate, Aloe Babadensis Leaf Juice, Cetyl Alcohol, Propanediol, Tocopheryl Acetate, Sodium Benzoate, Potassium Sorbate, Sodium Gluconate, Citric Acid, Phenoxyethanol, Biosaccharide Gum-A

  • PRINCIPAL DISPLAY PANEL

    Eczema Relief Cream

  • INGREDIENTS AND APPEARANCE
    ECZEMA RELIEF CREAM 
    colloidal oatmeal cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71521-025
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM GLUCONATE (UNII: R6Q3791S76)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
    DITTRICHIA VISCOSA WHOLE (UNII: 3SYW69FH88)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71521-025-5050 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/31/2021
    2NDC:71521-025-1515 g in 1 TUBE; Type 0: Not a Combination Product03/17/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/31/2021
    Labeler - Lavior Inc (080685327)
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