H-BI HEMORRHOIDS FORMULA (CALENDULA OFFICINALLIS, HAMAMELIS VIRGINIANA) OIL [HEALING NATURAL OILS LLC]

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H-BI HEMORRHOIDS FORMULA (CALENDULA OFFICINALLIS, HAMAMELIS VIRGINIANA) OIL [HEALING NATURAL OILS LLC]
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NDC 61077-005-11, 61077-005-33
Set ID a6f59c34-e252-4458-8ce4-01e2d3028aa8
Category HUMAN OTC DRUG LABEL
Packager Healing Natural Oils LLC
Generic Name
Product Class
Product Number
Application Number
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  • Active Ingredients:

    Calendula officinalis -12C HPUS

    Hamamelis virginiana - 6C HPUS 

  • Purpose

    Calendula officinalis - 12C HPUS (healing agent),

    Hamamelis virginiana - 6C HPUS (anus raw, bleeding).



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

  • Inactive Ingredients:

    Corylus avellana nut oil, Essential Oil Blend (Helichrysum italicum flower,

    Matricaria recutita flower, Pelargonium graveolens whole plant)

  • Indications:

    For the temporary relief of hemorrhoid symptoms such as burning,
    soreness and minor bleeding

  • 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-BI Hemorrhoids
    Formula

    Homeopathic

    For External Use Only

    005

    11ml (0.37 fl. oz)
    amoils.com

    BI Hemorrhoids Label 11

  • INGREDIENTS AND APPEARANCE
    H-BI HEMORRHOIDS FORMULA  
    calendula officinallis, hamamelis virginiana oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61077-005
    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
    HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - UNII:T7S323PKJS) HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK6 [hp_C]  in 11 mL
    Inactive Ingredients
    Ingredient NameStrength
    EUROPEAN HAZELNUT OIL (UNII: 8RQ2839AVG)  
    HELICHRYSUM ITALICUM FLOWER (UNII: P62Y550X24)  
    CHAMOMILE (UNII: FGL3685T2X)  
    PELARGONIUM GRAVEOLENS WHOLE (UNII: 0E553RP62F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61077-005-1111 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product11/06/2013
    2NDC:61077-005-3333 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(61077-005)
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