H-GOUT FORMULA- arnica montana, rhododendron oil

H-Gout Formula by

Drug Labeling and Warnings

H-Gout Formula by is a Homeopathic medication manufactured, distributed, or labeled by Healing Natural Oils LLC, King Bio Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Healing Natural Oils

H-Gout
Formula

Homeopathic

For External Use Only

135

11ml (0.37 fl. oz)

amoils.com

INGREDIENTS AND APPEARANCE

H-GOUT FORMULA 
arnica montana, rhododendron oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61077-135
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	12 [hp_C]  in 11 mL
RHODODENDRON AUREUM LEAF (UNII: IV92NQJ73U) (RHODODENDRON AUREUM LEAF - UNII:IV92NQJ73U)	RHODODENDRON AUREUM LEAF	6 [hp_C]  in 11 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61077-135-11	11 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	10/29/2014
2	NDC: 61077-135-33	33 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	10/29/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		10/29/2014

Labeler - Healing Natural Oils LLC (113679703)

Establishment
Name	Address	ID/FEI	Business Operations
King Bio Inc		617901350	manufacture(61077-135)