Label: H-MOLES FORMULA- calendula officinalis, phytolacca decandra, thuja occidentalis oil

  • NDC Code(s): 61077-125-11, 61077-125-33
  • 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 December 27, 2017

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  • Active Ingredients:

    Calendula officinalis - 12C HPUS

    Phytolacca decandra - 12C HPUS

    Thuja occidentalis - 12C HPUS
  • Purpose


    Calendula officinalis -12C HPUS (healing agent), 
    Phytolacca decandra - 12C HPUS (for moles),
    Thuja occidentalis - 12C HPUS (acts on skin, moles)

    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 (Lavandula officinalis flower bud, Melaleuca
    alternifolia leaf-branch, Melissa officinalis blossoms and whole plant,
    Thuja occidentalis leaf), Sesamum Indicum seed oil

  • Indications:

    Symptomatic treatment of benign skin moles

  • Directions:

    Adults and children 4 years and over:  Wash hands before and after use.
    Shake well and apply 1 or 2 drops to a cotton swab and dab directly to the moles 3x daily.
    Do not oversaturate or exceed dosage.

  • Warnings:

    For external use only.
    Only use on benign skin moles.
    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-Moles

    Formula

    Homeopathic

    For External Use Only

    125

    11ml (0.37 fl. oz)
    amoils.com

    Moles Label

  • INGREDIENTS AND APPEARANCE
    H-MOLES FORMULA  
    calendula officinalis, phytolacca decandra, thuja occidentalis oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61077-125
    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
    PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT12 [hp_C]  in 11 mL
    THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG12 [hp_C]  in 11 mL
    Inactive Ingredients
    Ingredient NameStrength
    LAVANDULA ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)  
    MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
    MELISSA OFFICINALIS (UNII: YF70189L0N)  
    THUJA OCCIDENTALIS LEAF (UNII: 0T0DQN8786)  
    SESAME OIL (UNII: QX10HYY4QV)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61077-125-1111 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product11/06/2013
    2NDC:61077-125-3333 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 Inc.617901350manufacture(61077-125)
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