Label: H- ECZEMA FORMULA- anacardium orientale, iris versicolor oil

  • NDC Code(s): 61077-019-11, 61077-019-33
  • Packager: Healing Natural Oils
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated December 11, 2017

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  • Active Ingredients:

    Anacardium orientale-12C HPUS
    Iris versicolor-12C HPUS
  • Purpose

    Anacardium orientale  - 12C HPUS  (itching, eczema),   
    Iris versicolor-12C HPUS  (eczema with nightly itching)

    The letters ‘HPUS’ indicate that the components    in this product    are officially
    monographed in the Homoeopathic Pharmacopoeia of the United States

  • Inactive Ingredients:

    Essential Oil Blend   
    (Cymbopogon martinii aerial parts, Daucus carota seed, Helichrysum italicum flower,   
    Lavandula officinalis flower bud, Matricaria recutita flower), Rosa Mosqueta seed oil,   
    Simmondsia chinensis seed oil

  • Indications:

    For the temporary relief of eczema symptoms such as dryness, itching and irritation.

  • Directions:

    Adults and Children 2 yrs and over: Wash hands before and after use.
    Shake well and apply 1 or 2 drops to a cotton swab or your finger and apply directly to the affected area 3x per day.
    Do not oversaturate or exceed dosage.

  • Warnings:

     For external use only.

    Perform skin test prior to initial use.




    If pregnant or breastfeeding consult a doctor before use.

    Keep out of reach of children.

    Keep away from eyes and mucous membranes. If swallowed get medical help
    or contact a Poison Control Center right away.

    Discontinue use if irritation occurs.

    Consult a doctor if symptoms worsen after 7 days.

  • DESCRIPTION

    Dist. by Healing Natural Oils 3830 Valley Ctr Dr, #705-526, San Diego, CA 92130, USA

  • PRINCIPAL DISPLAY PANEL

    Healing Natural Oils


    H-Eczema

    Formula


    Homeopathic


    For External Use Only


    019


    11ml (0.37 fl. oz)


    amoils.com

    Eczema Label

  • INGREDIENTS AND APPEARANCE
    H- ECZEMA FORMULA  
    anacardium orientale, iris versicolor oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61077-019
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SEMECARPUS ANACARDIUM JUICE (UNII: Y0F0BU8RDU) (SEMECARPUS ANACARDIUM JUICE - UNII:Y0F0BU8RDU) SEMECARPUS ANACARDIUM JUICE12 [hp_C]  in 11 mL
    IRIS VERSICOLOR ROOT (UNII: X43D4L3DQC) (IRIS VERSICOLOR ROOT - UNII:X43D4L3DQC) IRIS VERSICOLOR ROOT12 [hp_C]  in 11 mL
    Inactive Ingredients
    Ingredient NameStrength
    CYMBOPOGON MARTINI TOP (UNII: 7K1N3UZ6DU)  
    LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
    DAUCUS CAROTA SUBSP. SATIVUS SEED (UNII: 9M6AAX381U)  
    CHAMOMILE (UNII: FGL3685T2X)  
    HELICHRYSUM ITALICUM FLOWER (UNII: P62Y550X24)  
    JOJOBA OIL (UNII: 724GKU717M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61077-019-1111 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product11/06/2013
    2NDC:61077-019-3333 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product11/06/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic11/06/2013
    Labeler - Healing Natural Oils (113679703)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio Inc617901350manufacture(61077-019)
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