Active Ingredients:
Arnica Montana 12C HPUS, Rhododendron 6C HPUS
H-gout Formula Oil
FDA Label NDC 61077-135
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Healing Natural Oils Llc for the product H-gout Formula (NDC 61077-135). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients:, purpose, inactive ingredients:, indications:, directions:, warnings:, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
Otc - Pregnancy Or Breast Feeding
Do not use if pregnant or breastfeeding.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Other Safety Information
Keep away from eyes and mucous membranes. If swallowed get medical help or
contact a Poison Control
Center right away.
Otc - Stop Use
| Discontinue use if irritation occurs. |
Otc - Ask Doctor
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
H-goutlabel (H Goutlabel) 
* Please review the disclaimer below.
