Label: END-ITCH FOR ECZEMA 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 May 15, 2015

If you are a consumer or patient please visit this version.

  • OTC - ACTIVE INGREDIENT

    Colloidal Oatmeal 37.5%

  • INACTIVE INGREDIENTS

    Almond Oil. Beeswax, Jojoba Oil, Lanolin,
    Rosemary, Vitamin E Oil

  • OTC - KEEP OUT OF REACH OF CHILDREN SECTION

    If swallowed get medical help or contact
    a poison control center immediately.

  • WARNINGS

    For external use only
    Do not use on open cuts
    When using this product do not get into eyes
    Do not ingest

  • OTC - PURPOSE SECTION

    Temporarily relieves itching from eczema.

  • OTC - STOP USE SECTION

    Condition worsens
    Sensitivity develops or increases
    Symptoms last more than 7 days or
    clear up and occur again in a few days

  • INDICATIONS & USAGE

    Temporarily relieves itching from eczema.

  • DOSAGE & ADMINISTRATION

    Apply to affected area
    Rub in circular motion
    Apply as needed

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    End Itch Eczema.jpg

  • INGREDIENTS AND APPEARANCE
    END-ITCH FOR ECZEMA 
    end-itch for eczema cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60858-315
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL0.24 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALMOND OIL (UNII: 66YXD4DKO9)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    JOJOBA OIL (UNII: 724GKU717M)  
    lanolin (UNII: 7EV65EAW6H)  
    rosemary (UNII: IJ67X351P9)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60858-315-0394 mL in 1 BOTTLE; Type 0: Not a Combination Product05/15/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34705/15/2015
    Labeler - Crystal Connections, LLC (016582119)
    Establishment
    NameAddressID/FEIBusiness Operations
    American Pharmaceuticals and Cosmetics, Inc.038023805manufacture(60858-315)