TARGETED BODY BALM (OATMEAL) OINTMENT [SKINFIX, INC.]

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TARGETED BODY BALM (OATMEAL) OINTMENT [SKINFIX, INC.]
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NDC 61328-122-11
Set ID ada23bf4-4c10-4cc3-93b4-78e43ea16d31
Category HUMAN OTC DRUG LABEL
Packager Skinfix, Inc.
Generic Name
Product Class
Product Number
Application Number PART347
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  • Active Ingredients

    Colloidal Oatmeal 2%

  • Purpose

    Skin protectant

  • Uses

    Temporarily protects and helps relieve minor skin irritations and itching due to eczema, rash and dermatitis.

  • Warnings

    For external use only.

    When using this product

    • Avoid contact with 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
  • 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.

  • Other Information

    Store at 65-80°F. May stain fabrics. For adults and children two years of age and older.

  • Inactive Ingredients

    Allantoin, Beeswax, Butyrospermum Parkii (Shea) Butter, Glycine Soja (Soybean) Oil, Paraffin Wax, Petrolatum, Prunus Amygdalus (Sweet Almond) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Tocopherol, Zinc Oxide.

  • PRINCIPAL DISPLAY PANEL

    Skinfix_2oz_US_Targeted_Body_Balm_D16973_V9_R - box.jpg

  • INGREDIENTS AND APPEARANCE
    TARGETED BODY BALM 
    oatmeal ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61328-122
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALLANTOIN (UNII: 344S277G0Z)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    SHEANUT OIL (UNII: O88E196QRF)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    JOJOBA OIL (UNII: 724GKU717M)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61328-122-1160 g in 1 TUBE; Type 0: Not a Combination Product12/26/2018
    2NDC:61328-122-0515 g in 1 PACKAGE; Type 0: Not a Combination Product06/16/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34705/23/2015
    Labeler - Skinfix, Inc. (203158183)
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