Label: BODEWELL PSORIASIS CALMING- salicylic acid cream

  • NDC Code(s): 69423-598-23, 69423-598-59
  • 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

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Salicylic Acid 2%

  • Purpose

    Psoriasis

  • Uses

    • Helps eliminate skin itching, redness, irritation, flaking and scaling associated with psoriasis.
    • Helps prevent recurrence of the symptoms of psoriasis.
  • Directions

    Apply to affected areas one to four times daily or as directed by a doctor.

  • Warnings

    For external use only.

    When using this product

    • avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

    Stop use and ask a doctor if

    • condition worsens or does not improve after regular use of this product as directed.

    for prolonged periods without consulting a doctor.

    If condition covers a large area of the body, consult your doctor before using this product.

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

  • Inactive ingredients

    Water, glycerin, stearic acid, cetyl alcohol, carthamus tinctorius (safflower) seed oil, dimethicone, 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 U.S.A. of U.S. and/or Imported Ingredients

    bodewellskin.com

  • PRINCIPAL DISPLAY PANEL - 237 mL Tube

    bodewell

    psoriasis

    calming cream

    salicylic acid

    psoriasis cream

    8.0 FL OZ (237 mL)

    Label

  • INGREDIENTS AND APPEARANCE
    BODEWELL PSORIASIS CALMING 
    salicylic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69423-598
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SMILAX ARISTOLOCHIIFOLIA ROOT (UNII: NR100Y25G0)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508)  
    SAMBUCUS NIGRA WHOLE (UNII: 4X6JT95SYN)  
    SCROPHULARIA NODOSA (UNII: 7H443NUB2T)  
    POPULUS ALBA BARK (UNII: K12723D3GV)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    POPULUS TREMULOIDES BARK (UNII: 5543O0CEID)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)  
    ACHILLEA MILLEFOLIUM WHOLE (UNII: 2FXJ6SW4PK)  
    WATER (UNII: 059QF0KO0R)  
    ACHILLEA MILLEFOLIUM SEED (UNII: 8V0N54LMLR)  
    ALCOHOL (UNII: 3K9958V90M)  
    ALTHAEA OFFICINALIS ROOT (UNII: TRW2FUF47H)  
    BERBERIS VULGARIS ROOT BARK (UNII: 1TH8Q20J0U)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    MATRICARIA RECUTITA FLOWERING TOP (UNII: 3VNC7T6Z02)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    TUSSILAGO FARFARA LEAF (UNII: G2GH7V846Z)  
    VINCETOXICUM HIRUNDINARIA ROOT (UNII: 9R858U917W)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    LENS CULINARIS FRUIT (UNII: ZYZ076G9JH)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG)  
    VERONICA OFFICINALIS WHOLE (UNII: 9EHR580PSP)  
    MALVA SYLVESTRIS LEAF (UNII: 17H39B00T5)  
    NASTURTIUM OFFICINALE LEAF (UNII: 362629QKRT)  
    PIMPINELLA SAXIFRAGA WHOLE (UNII: LCL1491142)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69423-598-23237 mL in 1 TUBE; Type 0: Not a Combination Product02/15/2022
    2NDC:69423-598-5959 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 finalM03202/15/2022
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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