Label: BODEWELL ECZEMA DAILY CALMING- colloidal oatmeal cream

  • NDC Code(s): 69423-614-23, 69423-614-59
  • Packager: The Procter & Gamble Manufacturing Company
  • 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 September 1, 2022

If you are a consumer or patient please visit this version.

View All Sections
  • 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, poison ivy, oak or sumac, insect bites
  • Warnings

    For external use only.

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

    Do not get into eyes.

    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, dimethicone, glycerin, stearic acid, cetyl alcohol, cocos nucifera (coconut) oil, glyceryl stearate, niacinamide, sodium PCA, phenoxyethanol, petrolatum, triethanolamine, carbomer, caprylyl glycol, tocopheryl acetate, 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 - 237 mL Tube

    Bodewell

    eczema daily

    calming cream

    Colloidal Oatmeal

    Skin Protectant

    8.0 FL OZ (237 mL)

    Bodewell

  • INGREDIENTS AND APPEARANCE
    BODEWELL ECZEMA DAILY CALMING 
    colloidal oatmeal cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69423-614
    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
    LENS CULINARIS FRUIT (UNII: ZYZ076G9JH)  
    ALTHAEA OFFICINALIS ROOT (UNII: TRW2FUF47H)  
    PIMPINELLA SAXIFRAGA WHOLE (UNII: LCL1491142)  
    SMILAX ARISTOLOCHIAEFOLIA ROOT (UNII: NR100Y25G0)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TUSSILAGO FARFARA LEAF (UNII: G2GH7V846Z)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    CHAMOMILE (UNII: FGL3685T2X)  
    COCHLEARIA OFFICINALIS FLOWERING TOP (UNII: M87UN67CKR)  
    NASTURTIUM OFFICINALE LEAF (UNII: 362629QKRT)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG)  
    POPULUS ALBA BARK (UNII: K12723D3GV)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    VERONICA OFFICINALIS WHOLE (UNII: 9EHR580PSP)  
    SAMBUCUS NIGRA WHOLE (UNII: 4X6JT95SYN)  
    SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    VINCETOXICUM HIRUNDINARIA ROOT (UNII: 9R858U917W)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)  
    SCROPHULARIA NODOSA (UNII: 7H443NUB2T)  
    HORSE CHESTNUT (UNII: 3C18L6RJAZ)  
    BERBERIS VULGARIS ROOT BARK (UNII: 1TH8Q20J0U)  
    ACHILLEA MILLEFOLIUM WHOLE (UNII: 2FXJ6SW4PK)  
    ALCOHOL (UNII: 3K9958V90M)  
    MALVA SYLVESTRIS LEAF (UNII: 17H39B00T5)  
    POPULUS TREMULOIDES BARK (UNII: 5543O0CEID)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69423-614-23237 mL in 1 TUBE; Type 0: Not a Combination Product02/15/2022
    2NDC:69423-614-5959 mL in 1 TUBE; Type 0: Not a Combination Product09/05/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM01602/15/2022
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!