H-Gout Formula

Manufacturer
Healing Natural Oils LLC | King Bio Inc
Effective date
2024-12-11
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:29:29

Label at a glance#

ProductH-Gout Formula
Active ingredientARNICA MONTANA, RHODODENDRON AUREUM LEAF
Label structure8 sections

Dosage and administration

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.

Label contents#

Full prescribing information#

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Arnica Montana 12C HPUS, Rhododendron 6C HPUS

Purpose

OTC - PURPOSE SECTION

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:

INACTIVE INGREDIENT SECTION

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:

INDICATIONS & USAGE SECTION

For the temporary relief of gout symptoms.

Directions:

DOSAGE & ADMINISTRATION SECTION

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:

WARNINGS SECTION

For external use only.
Perform skin test prior to initial use.

OTC - PREGNANCY OR BREAST FEEDING SECTION

Do not use if pregnant or breastfeeding.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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 SECTION

Discontinue use if irritation occurs.

OTC - ASK DOCTOR SECTION

Consult a doctor if symptoms worsen after 7 days.

DESCRIPTION SECTION

Dist. by Healing Natural Oils 1041 N El Camino Real, #B-426, Encinitas, CA 92024 USA

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HealingNatural Oils


H-Gout
Formula

Homeopathic


For External Use Only

135

11ml (0.37 fl. oz)

amoils.com

H-GoutLabelH-GoutLabel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61077-135-11H-Gout Formula11 mL in 1 BOTTLE, DROPPEROIL113
61077-135-33H-Gout Formula33 mL in 1 BOTTLE, DROPPEROIL333

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61077-135H-GOUT FORMULA (ARNICA MONTANA, RHODODENDRON) OIL [HEALING NATURAL OILS LLC]3Current NDC, Legacy NDC, 2 package rows20241213_10b7b1ed-e5d4-4157-a7f7-65a8b2876245.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61077-13561077-135-11, 61077-135-33

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
H-Gout FormulaARNICA MONTANA, RHODODENDRONHealing Natural Oils LLC10b7b1ed-e5d4-4157-a7f7-65a8b28762452024-12-11WarningsExact identifier
ndc (package): 61077-135-11
ndc (package): 61077-135-33
ndc (product): 61077-135
ndc11 (package): 61077013511
ndc11 (package): 61077013533
spl id: 2906c142-d151-b339-e063-6294a90a4b76
spl set id: 10b7b1ed-e5d4-4157-a7f7-65a8b2876245

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.