Label: CBDMEDIC ECZEMA THERAPY- 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 December 25, 2019

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  • Active Ingredients and Purpose

    Colloidal Oatmeal 1% (Skin Protectant)

  • PURPOSE

  • Uses

    Temporarily protects and helps relieve minor skin irritations and itching due to
    • eczema
    • rashes

  • Warnings

    For external use only
    When using this product
    • do not get into eyes
    Stop use and ask a doctor if
    • condition worsens
    • symptoms persist for more than 7 days
    • symptoms clear up and occur again within a few days
    • excessive skin irritation develops
    Keep out of reach of children
    If swallowed, get medical help or contact a Poison Control Center immediately

  • KEEP OUT OF REACH OF CHILDREN

  • Directions

    apply as needed

  • Inactive ingredients

    Cottonseed oil, beeswax, CBD hemp oil, stearic acid, sorbic acid, jojoba seed oil, peppermint oil, chamomile oil, eucalyptus oil, zinc oxide, silver oxide

  • Questions?

    Call 1-844-422-3633

  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    CBDMEDIC ECZEMA THERAPY 
    colloidal oatmeal ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-751
    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:24909-751-401 in 1 CARTON09/01/2019
    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 finalpart34709/01/2019
    Labeler - AIDANCE SKINCARE & TOPICAL SOLUTIONS, LLC (018950611)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aidance Skincare & Topical Solutions, LLC018950611manufacture(24909-751) , label(24909-751)
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