Label: BODEWELL ECZEMA DAILY SOOTHING- colloidal oatmeal spray

  • NDC Code(s): 69423-615-11
  • Packager: The Procter & Gamble Manufacturing Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 15, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Colloidal Oatmeal 1%

  • Purpose

    Skin Protectant

  • Uses

    • Temporarily protects and helps relieve minor skin irritation and itching due to: eczema rashes
  • Warnings

    For external use only

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

    Do not get into eyes. If contact occurs, rinse eyes thoroughly with water.

    Don't spray directly into your face.

    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

  • Directions

    Apply as needed

  • INACTIVE INGREDIENT

    Water, glycerin, niacinamide, phenoxyethanol, 1,2-hexanediol, caprylyl glycol, aminomethyl propanol, sodium citrate, acrylates/C10-30 alkyl acrylate crosspolymer, polysorbate 20, citric acid, alcohol, hamamelis virginiana (witch hazel) bark/leaf extract, avena sativa (oat)
    seed extract, populus alba bark extract, populus tremuloides bark extract, cochlearia officinalis flower/leaf/stalk extract, phytolacca decandra root extract, lens esculenta (lentil) fruit extract, berberis vulgaris bark extract, scrophularia nodosa extract, veronica officinalis extract, sanguinaria canadensis rhizome/root extract, althaea officinalis root extract, chamomilla recutita (matricaria) flower extract, sambucus nigra extract, achillea millefolium extract, aesculus hippocastanum (horse chestnut) seed extract, malva sylvestris (mallow) leaf extract, nasturtium officinale leaf extract, smilax medica root extract, tussilago farfara (coltsfoot) leaf extract, pimpinella saxifraga extract, vincetoxicum hirundinaria root extract

  • Questions (or comments)?

    1-800-213-1873

  • SPL UNCLASSIFIED SECTION

    Dist. by The Procter & Gamble Distributing, LLC

    Cincinnati, OH 45202

    MADE IN USA of U.S. and/or Importing Ingredients

    bodewellskin.com

  • PRINCIPAL DISPLAY PANEL - 118 mL Bottle

    Bodewell

    eczema daily

    soothing spray

    Colloidal Oatmeal

    Skin Protectant

    4.0 FL OZ (118 mL)

    Bodewell

  • INGREDIENTS AND APPEARANCE
    BODEWELL ECZEMA DAILY SOOTHING 
    colloidal oatmeal spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69423-615
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    MALVA SYLVESTRIS LEAF (UNII: 17H39B00T5)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SMILAX ARISTOLOCHIAEFOLIA ROOT (UNII: NR100Y25G0)  
    TUSSILAGO FARFARA LEAF (UNII: G2GH7V846Z)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    LENS CULINARIS FRUIT (UNII: ZYZ076G9JH)  
    ALTHAEA OFFICINALIS ROOT (UNII: TRW2FUF47H)  
    PIMPINELLA SAXIFRAGA WHOLE (UNII: LCL1491142)  
    CHAMOMILE (UNII: FGL3685T2X)  
    COCHLEARIA OFFICINALIS FLOWERING TOP (UNII: M87UN67CKR)  
    NASTURTIUM OFFICINALE LEAF (UNII: 362629QKRT)  
    PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG)  
    POPULUS ALBA BARK (UNII: K12723D3GV)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SAMBUCUS NIGRA WHOLE (UNII: 4X6JT95SYN)  
    SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508)  
    HORSE CHESTNUT (UNII: 3C18L6RJAZ)  
    VINCETOXICUM HIRUNDINARIA ROOT (UNII: 9R858U917W)  
    HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)  
    SCROPHULARIA NODOSA (UNII: 7H443NUB2T)  
    BERBERIS VULGARIS ROOT BARK (UNII: 1TH8Q20J0U)  
    ACHILLEA MILLEFOLIUM WHOLE (UNII: 2FXJ6SW4PK)  
    ALCOHOL (UNII: 3K9958V90M)  
    POPULUS TREMULOIDES BARK (UNII: 5543O0CEID)  
    VERONICA OFFICINALIS WHOLE (UNII: 9EHR580PSP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69423-615-11118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product02/15/202204/30/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01602/15/202204/30/2024
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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