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 December 23, 2009

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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


  • PACKAGE INFORMATION

    NDC 37205-178-51

    LEADER                          SATISFACTION GUARANTEED

    Soothing
    Bath Treatment
    Regular Formulation

    100% Natural Colloidal Oatmeal
    Skin Protectant
    For fast temporary relief of itching , sore and sensitive skin due to:
    Poison Ivy, Poison Sumac, Poison Oak, Insect Bites, Rashes and Eczema

    *Compare to active ingredient of Aveeno®

    TOTAL NET WEIGHT 12 oz (340 g)
    8 INDIVIDUAL USE BATH PACKETS
    1.5 oz (42.5 g) EACH

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

    Distributed by Cardinal Health
    Dublin, OH 43017
    CIN 2434504
    www.myleader.com
    MADE IN USA

    All Leader Brand products are 100% satisfaction guaranteed or return to place of purchase for a full refund.

    image of carton

  • INGREDIENTS AND APPEARANCE
    SOOTHING BATH TREATMENT 
    colloidal oatmeal powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-178
    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:37205-178-518 in 1 CARTON
    142.5 g in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34707/21/2005
    Labeler - Cardinal Health (097537435)
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