FDA.reportPublic FDA data

Naturasil Gout

Manufacturer
Nature's Innovation, Inc.
Effective date
2012-12-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:44:07

Label at a glance#

ProductNaturasil Gout
Active ingredientCAPSICUM, ARNICA MONTANA, ST. JOHN'S WORT
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients:

Capsicum Annuum 3X HPUS

Arnica Montana 1X HPUS

Hypericum 6X HPUS

The letters HPUS indicate the component(s) in this product is (are) officially

monographed in the Homeopathic Pharmacopeia of the United States.

OTC - PURPOSE SECTION

Purpose

Gout Foot Pain Symptom Relief

Joint Pain, Neuralgia, and Stiffness Symptom Relief

Neuropathy, Tingling, Burning & Numbness Symptom Relief

INDICATIONS & USAGE SECTION

Uses: Symptomatic treatment of gout.

WARNINGS SECTION

Warnings: For external use only.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if pregnant or nursing.

OTC - DO NOT USE SECTION

Avoid contact with eyes. Do Not use by mouth, in nostrils, on wounds or damaged skin. Do not use if tamper evidence seal is broke.

OTHER SAFETY INFORMATION

In case of ingestion call Poison Control Center hotline immediately at 1-800-222-1222.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

Directions: SHAKE WELL!

Apply 10-20 drops and massage into areas with symptoms of gout. May be used 3-4 times daily. Pain will subside in 1-4 weeks. Some individuals may be sensitive to essential oils. Skin test for tolerability. If irritation or reaction occurs, discontinue use.

INACTIVE INGREDIENT SECTION

Ingredients: Cypress Leaf Oil, Eucalyptus Leaf Oil, Pelargonium Leaf Oil, Peppermint Leaf Oil, Sesame Seed Oil.

OTC - QUESTIONS SECTION

Questions? Comments? www.naturasil.com

866-371-2499 Mfd. by: Nature's Innovation, Inc.

2723 Brickton North Dr., Buford, GA 30518

Not tested on animals

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

100 Percent

Natural Plant Extracts

Naturasil

15 mL (.5 fl. oz.) e

Topical Liquid

Homeopathic Medicine

Gout

Gout 15ml LabelGout 15ml Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10893-462-152020-02-06C16284748780-19d75b9d0-bfaa-f424-e053-dadaa90a57ceNaturasil Gout
10893-462-152020-01-31C16284748780-19d75b9d0-bfaa-f424-e053-dadaa90a57ceNaturasil Gout

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ARNICA MONTANAACTIVE INGREDIENTO80TY208ZW1
CAPSICUMACTIVE INGREDIENT00UK7646FG1
ST. JOHN'S WORTACTIVE INGREDIENTUFH8805FKA1
ARNICA MONTANAACTIVE MOIETYO80TY208ZW1
CAPSICUMACTIVE MOIETY00UK7646FG1
ST. JOHN'S WORTACTIVE MOIETYUFH8805FKA1
CUPRESSUS SEMPERVIRENS LEAF OILINACTIVE INGREDIENTM7QUY89S4O1
EUCALYPTUS OILINACTIVE INGREDIENT2R04ONI6621
GERANIUM OIL, ALGERIAN TYPEINACTIVE INGREDIENT5Q1I94P4WG1
PEPPERMINT OILINACTIVE INGREDIENTAV092KU4JH1
SESAME OILINACTIVE INGREDIENTQX10HYY4QV1

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
10893-46210893-462-15

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
CAPSICUM00UK7646FGACTIM
ARNICA MONTANAO80TY208ZWACTIM
ST. JOHN'S WORTUFH8805FKAACTIM
CUPRESSUS SEMPERVIRENS LEAF OILM7QUY89S4OIACT
EUCALYPTUS OIL2R04ONI662IACT
GERANIUM OIL, ALGERIAN TYPE5Q1I94P4WGIACT
PEPPERMINT OILAV092KU4JHIACT
SESAME OILQX10HYY4QVIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 24 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SESAME OILSESAME OILQX10HYY4QVINJECTION / INTRAMUSCULAR70 %v/vExact identifier — unii candidate
2 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHLOZENGE / ORAL12 mgExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHTABLET, ORALLY DISINTEGRATING / ORAL3 mgExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHSUSPENSION / ORAL100 mg/1mlExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHSHAMPOO / TOPICAL0.2 %w/wExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHSOLUTION / ORAL53 mgExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHSOLUTION / DENTAL0.04 %v/vExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHOINTMENT / TOPICAL0.2 %w/wExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHFILM, SOLUBLE / BUCCAL3 mgExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHPOWDER, DENTIFRICE / DENTALNAExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHPASTE, DENTIFRICE / DENTAL49.3 %w/wExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHCAPSULE / ORAL60 mgExact identifier — unii candidate
21 equally ranked IID candidates
EUCALYPTUS OILEUCALYPTUS OIL2R04ONI662SYRUP / ORALNAExact identifier — unii candidate
PEPPERMINT OILPEPPERMINT OILAV092KU4JHTABLET / SUBLINGUAL0.15 mgExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHFILM / BUCCAL12 mgExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHCONCENTRATE / ORAL0.05 mgExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHGUM, CHEWING / BUCCAL526 mgExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHGUM, CHEWING / ORAL526 mgExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHELIXIR / ORAL0.04 mg/1mlExact identifier — unii candidate
21 equally ranked IID candidates
SESAME OILSESAME OILQX10HYY4QVCAPSULE / ORAL2325 mgExact identifier — unii candidate
2 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHSYRUP / ORAL120 mgExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHPOWDER / SUBLINGUAL1 mgExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHTABLET / ORAL28 mgExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHSPRAY, METERED / SUBLINGUAL1 mgExact identifier — unii candidate
21 equally ranked IID candidates

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
bf6fe716-4a6e-4800-8633-d0ce06ec03ee187c6936-5b9d-4814-a584-733431c9f3f72012-12-03WarningsExact identifier
spl id: bf6fe716-4a6e-4800-8633-d0ce06ec03ee
spl set id: 187c6936-5b9d-4814-a584-733431c9f3f7

Reported adverse events (FAERS/openFDA)#

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