Label: CBDMEDIC ECZEMA- colloidal oatmeal ointment

  • 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 March 6, 2019

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  • Active Ingredients and Purpose

    Colloidal Oatmeal 1% (Skin Protectant)

  • Uses

    To relieve symptoms associated with eczema, psoriasis, and severe dry, itchy and flaky skin.

  • Warnings

    For external use only. Do not use on wounds or damaged skin. Avoid contact with eyes. If symptoms persist for more than seven days, discontinue use and consult a physician.

  • KEEP OUT OF REACH OF CHILDREN

    If pregnant or breast feeding, contact a physician prior to use. Keep out of reach of children. If swallowed, consult a physician.

  • Directions:

    Adults and children 12 years of age and older: Massage into affected skin. Reapply up to 4 times daily. Store at room temperature.
    Children under 12 years of age: ask a doctor.

  • INDICATIONS & USAGE

  • Inactive ingredients

    Beeswax (organic), chamomile oil, cotton seed oil, eucalyptus oil, hemp extract (THC-free), jojoba seed oil, peppermint oil, silver oxide, sorbic acid, stearic acid (vegetable derived), zinc oxide.

  • PRINCIPAL DISPLAY PANEL

    CBDMEDIC Eczema

  • INGREDIENTS AND APPEARANCE
    CBDMEDIC ECZEMA 
    colloidal oatmeal ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-730
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WHITE WAX (UNII: 7G1J5DA97F)  
    CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839)  
    COTTONSEED OIL (UNII: H3E878020N)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    HEMP (UNII: TD1MUT01Q7)  
    JOJOBA OIL (UNII: 724GKU717M)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    SILVER OXIDE (UNII: 897WUN6G6T)  
    SORBIC ACID (UNII: X045WJ989B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24909-730-401 in 1 CARTON03/06/2019
    140 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/06/2019
    Labeler - AIDANCE SKINCARE & TOPICAL SOLUTIONS, LLC (018950611)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aidance Skincare & Topical Solutions, LLC018950611manufacture(24909-730) , label(24909-730)
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