Label: OHEAL MANUKA HONEY ECZEMA CREAM- manuka honey eczema cream cream

  • NDC Code(s): 83176-011-01
  • Packager: Dr.luke Healthcare LLC
  • 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 June 26, 2023

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  • Active Ingredient

    Clotrimazole 1%

  • Purpose

    Antifungal

  • Use

    For Dermatitis, Psoriasis, Eczema, Rosacea, Shingles, Oily, Dry or Cracked Skin, General Skin Irritation, and more.

  • Warnings

    1. For external use only.
    2. Stop using it and ask the doctor if you are allergic to this product.
    3. Avoid contact with eyes, flush with water immediately if it gets into eyes.
    4. If you are pregnant or breastfeeding, please don’t use it.
    5. Keep out of reach of children.
    6. Do not ingest.
    7. Do not use if safety seal is broken or missing. Wash hands after use.

  • Do not use

    If you are pregnant, breastfeeding
    On children under 10 years
    On unhealed wounds after surgery
    If you are allergic to this product

  • Stop Use

    You are experiencing severe allergic reactions, local ulcers, heavy rash, edema, or severe pain.

  • Ask Doctor

    If you are allergic, feel unwell, please seek medical advice

  • Keep Oot Of Reach Of Children

    Please do not allow unconscious persons to come into contact with.

  • Directions

    1.Before using this product, wash and dry the affected area with warm water.
    2.Apply an appropriate amount, and knead gently for two minutes to absorb it to achieve better results fully 2-3 times a day.
    3.Use it for 3-5 days after symptoms disappear to prevent recurrence.

  • Other information

    If swallowed, rinse immediately with water, and get medical help or contact a poison control center right away.

  • Inactive ingredients

    Rhinaca nthus Nasutus, HerbaViolae,
    EeuphorbiaHir tall, Murrayaexotica L.,
    Manthill1, Dryobala NopsSpp,
    Sophora Flavescens, Manuka Honey,
    CnidiumMonniericuss, ILAtin Title,
    CortexDictamnil, Mosiacavaerieilev1,
    RhizomaSmi Lacis alabrael, Phel,
    lodendrn Amurenserupr1,
    IFischereuphobiaR oot,
    IGleditsiasinenesislinn1,
    StemonaTuberosaLour.

  • Questions

    www.ohealpro.com

    Info@ohealpro.com

  • PACKAGE LABEL.

    0

  • INGREDIENTS AND APPEARANCE
    OHEAL MANUKA HONEY ECZEMA CREAM 
    manuka honey eczema cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83176-011
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    MINT (UNII: FV98Z8GITP)  
    LEPTOSPERMUM SCOPARIUM TOP (UNII: A5611M841M)  
    SMILAX GLABRA TUBER (UNII: PES3YXA3LR)  
    STELLERA CHAMAEJASME WHOLE (UNII: 80N0P0DD9J)  
    STEMONA TUBEROSA ROOT (UNII: 7S9328671Z)  
    MURRAYA PANICULATA WHOLE (UNII: Y8ZAA3Z7WU)  
    VIOLA PHILIPPICA WHOLE (UNII: O176VC3N54)  
    EUPHORBIA HIRTA (UNII: L13YF113GN)  
    PHELLODENDRON AMURENSE BARK (UNII: PBG27B754G)  
    BASSIA SCOPARIA WHOLE (UNII: 240G38P85Z)  
    DICTAMNUS DASYCARPUS ROOT BARK (UNII: LA97176ILS)  
    SELENICEREUS GRANDIFLORUS FLOWER (UNII: II877K4UNR)  
    CIRSIUM JAPONICUM ROOT (UNII: JQN9IR918W)  
    CNIDIUM MONNIERI FRUIT OIL (UNII: JK0MS9P8YL)  
    SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)  
    RHINACANTHUS NASUTUS WHOLE (UNII: QW70YFP724)  
    BORNEOL (UNII: M89NIB437X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83176-011-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product06/10/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM00506/10/2023
    Labeler - Dr.luke Healthcare LLC (118868014)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dr.luke Healthcare LLC118868014label(83176-011) , manufacture(83176-011)
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