Label: H-GOUT FORMULA- arnica montana, rhododendron oil

  • NDC Code(s): 61077-135-11, 61077-135-33
  • 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 11, 2024

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  • Active Ingredients:

    Arnica Montana 12C HPUS, Rhododendron 6C HPUS

  • Purpose

    Arnica Montana 12C HPUS (join pain, neuralgia and stiffness), Rhododendron 6C HPUS (Rheumatic, gouty symptoms, Gouty inflammation of toe-joint)

    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 (Boswellia carterii oleo-gum resin, Citrus limonum peel, Juniperus communis berry, Lavandula officinalis flower bud, Matricaria recutita flower)

  • Indications:

    For the temporary relief of gout symptoms.

  • 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 on affected areas 3x daily. 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 1041 N El Camino Real, #B-426, Encinitas, CA 92024 USA

  • Principal Display Panel

    HealingNatural Oils


    H-Gout
    Formula

    Homeopathic

    For External Use Only

    135

    11ml (0.37 fl. oz)

    amoils.com

    H-GoutLabel

  • INGREDIENTS AND APPEARANCE
    H-GOUT FORMULA 
    arnica montana, rhododendron oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61077-135
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA12 [hp_C]  in 11 mL
    RHODODENDRON AUREUM LEAF (UNII: IV92NQJ73U) (RHODODENDRON AUREUM LEAF - UNII:IV92NQJ73U) RHODODENDRON AUREUM LEAF6 [hp_C]  in 11 mL
    Inactive Ingredients
    Ingredient NameStrength
    EUROPEAN HAZELNUT OIL (UNII: 8RQ2839AVG)  
    FRANKINCENSE OIL (UNII: 67ZYA5T02K)  
    LEMON JUICE (UNII: AGN709ANTJ)  
    JUNIPER BERRY OIL (UNII: SZH16H44UY)  
    LAVANDULA ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)  
    CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61077-135-1111 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product10/29/2014
    2NDC:61077-135-3333 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product10/29/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic10/29/2014
    Labeler - Healing Natural Oils LLC (113679703)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio Inc617901350manufacture(61077-135)
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