Label: H-PSORIASIS FORMULA- calendula officinalis, iris versicolor oil

  • NDC Code(s): 61077-047-11, 61077-047-33
  • Packager: Healing Natural Oils LLC
  • 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 June 14, 2023

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  • Active Ingredients:

    Calendula officinalis - 12C HPUS

    Iris versicolor - 12C HPUS

  • Purpose


    Calendula officinalis -12C HPUS (healing agent),
    Iris versicolor -12CHPUS (psoriasis, irregular patches with shining scales)

    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 (Cedrus atlantica wood shavings, Melaleuca alternifolia leaf-branch, Melaleuca minor leaf), Rosa mosqueta seed oil, Simmondsia chinensis seed oil, Triticum vulgare kernel oil

  • Indications:

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

  • Directions:

    Adults and Children 4 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.


    Do not use if pregnant or breastfeeding.


    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-Psoriasis

    Formula

    Homeopathic

    For External Use Only

    047

    11ml (0.37 fl. oz)

    amoils.com

    1

    2

  • INGREDIENTS AND APPEARANCE
    H-PSORIASIS FORMULA 
    calendula officinalis, iris versicolor oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61077-047
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP12 [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
    CEDRUS ATLANTICA BARK OIL (UNII: ZX5QRE4U60)  
    MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
    JOJOBA OIL (UNII: 724GKU717M)  
    WHEAT GERM OIL (UNII: 14C97E680P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61077-047-1111 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product11/06/2013
    2NDC:61077-047-3333 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 LLC (113679703)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio Inc617901350manufacture(61077-047)
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