Label: GENTLE ECZEMA BALM- colloid oatmeal stick

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 October 12, 2011

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  • ACTIVE INGREDIENT

    Active Ingredient: Colloid Oatmeal USP (0.8%)

  • PURPOSE

    Purpose : Skin Protectant

               

  • WARNINGS

    Warnings: For external use only

    Stop use and ask 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





  • INDICATIONS & USAGE


    Uses :

    * Temporary protects and helps relieve minor skin irritation and itching due to * eczema


  • DOSAGE & ADMINISTRATION

    Direction ; Apply as needed


  • INACTIVE INGREDIENT

    Fragrance


  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    GENTLE ECZEMA BALM 
    colloid oatmeal stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45765-5142
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Oatmeal (UNII: 8PI54V663Y) (Oatmeal - UNII:8PI54V663Y) Oatmeal0.112 g  in 14 g
    Inactive Ingredients
    Ingredient NameStrength
    SHEA BUTTER (UNII: K49155WL9Y)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    CERESIN (UNII: Q1LS2UJO3A)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:45765-5142-014 g in 1 CASE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34710/12/2010
    Labeler - Naterra International INC. (879056786)
    Registrant - Beautymanufacturing Solutions Corperation (783200723)
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