Label: AVENE XERACALM ECZEMA CALMING RELIEF BALM- colloidal oatmeal cream

  • NDC Code(s): 64760-777-01, 64760-777-02
  • Packager: Pierre Fabre USA Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 6, 2024

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  • Drug Facts

  • 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

    When using this product - do not get into eyes

  • Stop use and ask a doctor

    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.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Apply as needed. For targeted areas on body, face and hands.
  • Inactive ingredients

    Water (aqua), Propanediol, Caprylic/capric triglyceride, Glyceryl stearate, Cetearyl alcohol, Cetyl alcohol, Glycerin, 1,2 Hexanediol, Arginine, Caprylyl glycol, Ceramide NP, Citric acid, Maltodextrin, Oenothera biennis (evening primrose) oil, Ophiopogon japonicus root extract, Polyacrylate-13, Polyisobutene, Polysorbate 20, Sodium benzoate, Sodium hydroxide, Sorbitan isostearate, Tocopherol.

  • Questions?

    1-866-41-AVENE (28363).

  • Tube 337123

    Tube 337123

  • INGREDIENTS AND APPEARANCE
    AVENE XERACALM ECZEMA CALMING RELIEF BALM 
    colloidal oatmeal cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64760-777
    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
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    WATER (UNII: 059QF0KO0R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ARGININE (UNII: 94ZLA3W45F)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ACONITIC ACID (UNII: 93371T1BXP)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)  
    POLYACRYLATE-13 (UNII: FS2D4T67EA)  
    POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)  
    OPHIOPOGON JAPONICUS ROOT (UNII: 90PS6JV9GZ)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    CERAMIDE NP (UNII: 4370DF050B)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64760-777-01100 g in 1 TUBE; Type 0: Not a Combination Product05/01/2024
    2NDC:64760-777-021 in 1 BOX06/03/2024
    25 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01605/01/2024
    Labeler - Pierre Fabre USA Inc. (117196928)
    Registrant - Pierre Fabre USA Inc. (117196928)
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