Indications and uses
Uses+: For symptomatic treatment of gout joint pain and inflammation. + As per various homeopathic materia medicas. These uses have not been evaluated by the FDA, and product has not been clinically tested.
Gout Calm
- Manufacturer
- Silver Star Brands | Vitality Works
- Effective date
- 2023-03-04
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 02:20:26
Label at a glance#
ProductGout Calm
Active ingredientANTIMONY TRISULFIDE, BERBERIS VULGARIS FRUIT, LITHIUM CARBONATE
Label structure10 sections
Dosage and administration
Directions: Shake well before using. Spray onto entire affected area and massage into skin every 2 hours until pain begins to subside. Adults and children over 12 years of age.
Label contents#
Full prescribing information#
HPUS* Active ingredients
HPUS* Active ingredients - Equal volumes of each ingredient as follows: Antimonium crudum (6C), Berberis vulgaris (30C), Lithium carbonicum (6C).
*"HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.
Uses+:
Uses+: For symptomatic treatment of gout joint pain and inflammation.
+ As per various homeopathic materia medicas. These uses have not been evaluated by the FDA, and product has not been clinically tested.
Warnings
Warnings: If symptoms persist or worsen, discontinue use immediately and consult a healthcare professional.
If pregnant or breast-feeding, ask a health care professional before use.
Keep out of reach of children.
For external use only.
Avoid using near eyes or mouth.
If swallowed, get medical help or contact a Poison Control Center immediately.
Some individuals may be sensitive to essential oils. If irritation or reaction occurs, discontinue use.
Directions
Directions: Shake well before using.
Spray onto entire affected area and massage into skin every 2 hours until pain begins to subside.
Adults and children over 12 years of age.
OTHER SAFETY INFORMATION
Other information:
Intended to complement, not replace, standard medical care.
Tamper resistant for your protection. Use only if safety seal is intact.
Inactive ingredients
Inactive ingredients: Basil essential oil, black pepper essential oil, celery essential oil, grapeseed oil.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health care professional before use.
OTC - PURPOSE SECTION
HPUS* Active ingredients Purpose+
Equal volumes of each ingredient as follows:
Antimonium crudum (6C)..................................Stiffness, swelling
Berberis vulgaris (30C).....................................Burning pain
Lithium carbonicum (6C)..................................Joint pain
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| b3053bb1-353b-4a0b-bca5-28fe7228957c | Product name | 2 | 20250124 |
| 8ce6e144-236f-b7be-f690-f06e0c8c6bd3 | Product name | 2 | 20170725 |
| f09af6ee-c6dd-d0ce-77ad-93508bcdaced | Product name | 4 | 20161205 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68703-218-02 | 2025-01-30 | C162847 | 48780-1 | ba0f9c33-0fb2-a910-e053-dadaa90a0b85 | Healthful™ Naturals GoutCalm - 59 ml |
| 68703-218-02 | 2023-03-06 | C162847 | 48780-1 | ba0f9c33-0fb2-a910-e053-dadaa90a0b85 | Healthful™ Naturals GoutCalm - 59 ml |
| 68703-218-02 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-0fb2-a910-e053-dadaa90a0b85 | Healthful™ Naturals GoutCalm - 59 ml |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68703-218-02 | Gout Calm | 59 mL in 1 BOTTLE, SPRAY | SPRAY | 59 | 2 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Gout Calm
- Antimonium crudum, Berberis vulgaris, Lithium carbonicum
- BLACK PEPPER OIL
- GRAPE SEED OIL
- ANTIMONY TRISULFIDE
- BASIL OIL
- CELERY SEED OIL
- BERBERIS VULGARIS FRUIT
- LITHIUM CARBONATE
- LITHIUM CATION
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 68703-218 | 68703-218-02 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| BLACK PEPPER OIL | U17J84S19Z | IACT |
| GRAPE SEED OIL | 930MLC8XGG | IACT |
| ANTIMONY TRISULFIDE | F79059A38U | ACTIB |
| BASIL OIL | Z129UMU8LE | IACT |
| CELERY SEED OIL | 8MBL58728K | IACT |
| BERBERIS VULGARIS FRUIT | 6XEF22AHC3 | ACTIB |
| LITHIUM CARBONATE | 2BMD2GNA4V | ACTIB |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| f61eb0d3-4d22-85d3-e053-2a95a90ac8bc | 82e2da70-804e-eebd-e053-2a91aa0aff5b | 2023-03-04 | Warnings | f61eb0d3-4d22-85d3-e053-2a95a90ac8bc 82e2da70-804e-eebd-e053-2a91aa0aff5b |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.