Label: RENEW INTENSIVE SKIN THERAPY TARGETED ECZEMA TREATMENT- colloidal oatmeal cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 29, 2024

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  • Active Ingredients

    Colloidal oatmeal 1%

  • Purpose

    Skin protectant

  • INDICATIONS & USAGE

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

    • rashes
    • eczema
  • Warnings

    For external use only

  • WHEN USING

    When using this product avoid contact with eyes

  • STOP USE

    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.

  • DOSAGE & ADMINISTRATION

    Directions

    • apply as needed or as directed by a doctor
    • for children under 2 years of age: ask a doctor
  • OTHER SAFETY INFORMATION

    Other information

    • for mild to moderate eczema
    • store below 86 F (30 C)
  • INACTIVE INGREDIENT

    water, glycerin, petrolatum, distearyldimonium chloride, isopropyl palmitate, cetyl alcohol, allantoin, benzyl alcohol, citric acid

  • PRINCIPAL DISPLAY PANEL

    Renew Intensive Skin Therapy Targeted Eczema Treatment label.jpg

  • INGREDIENTS AND APPEARANCE
    RENEW INTENSIVE SKIN THERAPY  TARGETED ECZEMA TREATMENT
    colloidal oatmeal cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54473-410
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL0.5 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    ALLANTOIN (UNII: 344S277G0Z)  
    DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    WATER (UNII: 059QF0KO0R)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54473-410-0150 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product01/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)01/01/2024
    Labeler - Melaleuca Inc. (139760102)
    Registrant - Melaleuca Inc. (079711683)
    Establishment
    NameAddressID/FEIBusiness Operations
    Melaleuca Inc.079711683manufacture(54473-410)
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