Label: DERMOIA MANUKA HONEY ECZEMA CREAM- oatmeal cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 6, 2023

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  • Drug Facts

  • Active Ingredients

    Colloidal Oatmeal 1%

    Purpose

    Skin Protectant

  • Uses

    • Temporarily protects and helps relieve minor skin irritation and itching due to:
    • rashes
    • eczema
    • poison ivy, oak, or sumac
    • insect bites
  • Warnings:

    For external use only

    When using this product

    • 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

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

    If pregnant or beast-feeding,

    ask a health professional before use.

  • Directions

    • Apply as needed
  • Inactive Ingredients:

    Allantoin, Aloe Barbadensis Leaf (aloe Vera Gel) Juice, Arnica Montana Flower Extract, Aqua (Deionized Water), Butyrospermum Parkii (Shea) Butter, Calendula Officinalis Extract, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Ceramide NG, Ceramide NP, Cetearyl Alcohol, Chamomilia Recutita (Chamomile) Extract, Citric Acid, dl-Panthenol, Ethylhexylglycerin, Euterpe Oleracea (Acai) Extract, Glycerin, Glyceryl Stearate, Hyaluronic Acid, Isopropyl Myristate, Magnesium Aluminum Silicate, Manuka Honey, Melaleuca Alternifolia (Tea Tree) Oil, Niacinamide, Linum Usitatissimum (Flaxseed) Oil, Oryza Sativa (Rice) Bran Oil, Passiflora Incarnata (Passion Fruit) Extract, Persea Gratissima (Avocado) Oil, Phenoxyethanol, Simmondsia Chinensis (Jojoba) Oil, Stearic Acid, Tocopheryl Acetate (Vitamin E), Xanthan Gum.

  • Other Information:

    • Protect the product in this container from excessive heat and direct sun
  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    DERMOIA MANUKA HONEY ECZEMA CREAM 
    oatmeal cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83524-407
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALLANTOIN (UNII: 344S277G0Z)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    WATER (UNII: 059QF0KO0R)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CERAMIDE NG (UNII: C04977SRJ5)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CHAMOMILE (UNII: FGL3685T2X)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ACAI (UNII: 46AM2VJ0AW)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    FLAX SEED (UNII: 4110YT348C)  
    RICE BRAN OIL (UNII: LZO6K1506A)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    JOJOBA OIL (UNII: 724GKU717M)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83524-407-00120 mL in 1 JAR; Type 0: Not a Combination Product06/05/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01606/05/2023
    Labeler - TREASUREWISE LLC (112606067)
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