BABY GENTLE ECZEMA SHEER FACE (COLLOIDAL OATMEAL) OINTMENT [SKINFIX, INC.]

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BABY GENTLE ECZEMA SHEER FACE (COLLOIDAL OATMEAL) OINTMENT [SKINFIX, INC.]
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NDC 61328-114-12
Set ID 284944d5-1419-455d-9672-e5541989436a
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 3%

  • 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.

    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

    If swallowed get medical help or contact a Poison Control Center right away.

  • Directions

    Apply to affected areas as needed.

  • OTHER INFORMATION

    STORE AT 65-75°F. MAY STAIN FABRICS. 

  • Inactive Ingredients

    Allantoin, Beeswax, Helianthus Annuus (Sunflower) Oil, paraffin, petrolatum, simmondsia chinensis (jojoba) seed oil, tocopherol.

  • PRINCIPAL DISPLAY PANEL

    US_Gentle_Eczema_Sheer_2oz_V2.jpg

  • INGREDIENTS AND APPEARANCE
    BABY GENTLE ECZEMA SHEER FACE 
    colloidal oatmeal ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61328-114
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALLANTOIN (UNII: 344S277G0Z)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    JOJOBA OIL (UNII: 724GKU717M)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61328-114-1255 g in 1 TUBE; Type 0: Not a Combination Product02/27/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34702/27/2017
    Labeler - Skinfix, Inc. (203158183)
    Registrant - Skinfix, Inc. (203158183)
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