Label: YUMA- oatmeal soap

  • 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 January 5, 2011

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  • Active Ingredients

    Colloidal Oatmeal (avena sativa) 1%

  • Purpose

    Skin Protectant

  • INDICATIONS & USAGE

    Uses • temporarily protects and helps relieve minor skin irritation and itching due to •poison ivy, oak or sumac •insect bites •rashes

  • WARNINGS

    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

    •do not use on •deep or puncture wounds •animal bites

    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

  • INACTIVE INGREDIENT

    Inactive Ingredients Vegetable soap base (sodium palmate, sodium cocoate and/or sodium palm kemelate, water, glycerin, pentasodium pentetate), kaolin clay (kaolin), cocoa butter (theobroma cacao), sodium chloride, aloe vera leaf (aloe barbadensis), rosemary oil (rosmarinus officinalis), menthol (mentha arvensis), allantoin (ureidohydantoin), green tea (camelia sinensis), lemongrass (cymbopogon citratus), ammonium alum, eucalyptus oil (eucalyptus globulus), peppermint oil (mentha piperita), zinc ricinoleate, FD&C Yellow No. 10, FD&C Green No. 5.

  • PRINCIPAL DISPLAY PANEL

    Package Label - Principal Display Panel – Yuma Backwoods Survivor Carton

    Principal Display Panel – Yuma Backwoods Survivor Carton

  • INGREDIENTS AND APPEARANCE
    YUMA 
    oatmeal soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75933-1425
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL1.205 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE (UNII: V5VD430YW9)  
    ROSEMARY (UNII: IJ67X351P9)  
    MENTHA ARVENSIS FLOWER OIL (UNII: Q129Z1W6Y2)  
    ALLANTOIN (UNII: 344S277G0Z)  
    CAMELLIA SINENSIS ROOT (UNII: 8H54O0V2K3)  
    WEST INDIAN LEMONGRASS OIL (UNII: 5BIA40E9ED)  
    POTASSIUM ALUM (UNII: 1L24V9R23S)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    ZINC RICINOLEATE (UNII: BOH1Z111J2)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)  
    SODIUM COCOATE (UNII: R1TQH25F4I)  
    SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PENTASODIUM PENTETATE (UNII: 961TOZ5L7T)  
    KAOLIN (UNII: 24H4NWX5CO)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75933-1425-11 in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34706/01/2011
    Labeler - Yuma Outdoors LLC (965948461)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vanguard Soap LLC831404954MANUFACTURE
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