Label: RELIEF SOOTHING BATH TREATMENT- colloidal oatmeal granule, effervescent

  • 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 November 15, 2022

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  • ACTIVE INGREDIENT

    Active Ingredient (in each packet)                      Purpose

    colloidal oatmeal, 100%                                    Skin protectant

    Uses    Temporarily protects and relieves minor skin irritation and itching due to one or more of the following

    rashes

    eczema

    insect bites

    sunburn

    poison ivy, oak, or sumac

    Keep out of reach of children. If swallowed, get medical help or contact a poison Control Center right away.

    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

    Warning For external use only

    Directions
    Turn warm water faucet on to full force.
    Slowly sprinkle one packet of colloidal oatmeal directly into tub or container.
    stir any colloidal oatmeal that may have settled at 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.

    No inactive ingredients

  • PRINCIPAL DISPLAY PANEL

    Relief

    Soothing Bath Treatment

    6 single use packets

    Total net Wt. 9 oz. (255g)

    box

    bag

  • INGREDIENTS AND APPEARANCE
    RELIEF SOOTHING BATH TREATMENT 
    colloidal oatmeal granule, effervescent
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:22431-359
    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:22431-359-033 in 1 BOX09/17/2010
    1NDC:22431-359-026 in 1 BOX
    1NDC:22431-359-0142.5 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34709/17/2010
    Labeler - Blue Cross Laboratories, Inc. (008298879)
    Registrant - Blue Cross Laboratories, Inc. (008298879)