Label: SOOTHING BATH TREATMENT- colloidal oatmeal powder

  • 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 February 12, 2010

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  • ACTIVE INGREDIENT (in each packet)

    Colloidal Oatmeal, 100%

  • PURPOSE

    Skin Protectant
  • USE

    temporarily protects and helps relieve minor skin irritation and itching due to one or more of the following:
    • rashes
    • eczema
    • poison ivy, oak, or sumac
    • insect bites
  • WARNINGS

    For external use only.




    When using this product

    • do not get into eyes
    • in some skin conditions, soaking too long may overdry
    • to avoid slipping, use mat in tub or shower

    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.

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

  • DIRECTIONS

    • Turn warm water faucet on to full force.
    • Slowly sprinkle 1 packet of colloidal oatmeal directly under the faucet into the tub or container.
    • Stir any colloidal oatmeal that may have settled to the bottom.
    • Soak affected area for 15-30 minutes as needed or as directed by a doctor.
    • Pat dry (do not rub) to keep a thin layer on the skin.
  • SPL UNCLASSIFIED SECTION


  • STORAGE AND HANDLING


  • INACTIVE INGREDIENT


  • QUESTIONS


  • CARTON INFORMATION

    Soothe and Bathe

    *Compare to active ingredient of Aveeno®

    Soothing
    Bath Treatment
    100% Colloidal Oatmeal

    Skin Protectant
    For fast, soothing relief of poison ivy, poison sumac, poison oak, insect bites, rashes and eczema

    REGULAR FORMULA
    Fragrance Free

    8 Single use Packets - 1.5 oz. (42.5 g ) each
    Total Net Wt. 12 oz. (340 g)

    *This product is not manufactured or distributed by Johnson and Johnson, owner of the registered trademark, Aveeno®.

    Triad Group, Inc.
    Brookfield, WI 53045
    MADE IN USA
    www.triad-group.net

    Fragrance Free
    Not Tested on Animals

    image of carton

  • INGREDIENTS AND APPEARANCE
    SOOTHING BATH TREATMENT 
    colloidal oatmeal powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50730-7100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL1 g  in 1 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50730-7100-18 in 1 CARTON
    142.5 g in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34711/01/1995
    Labeler - Triad Group (050259597)
    Establishment
    NameAddressID/FEIBusiness Operations
    Triad Group050259597manufacture
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