GOUT CALM- antimonium crudum, berberis vulgaris, lithium carbonicum spray

Gout Calm by

Drug Labeling and Warnings

Gout Calm by is a Homeopathic medication manufactured, distributed, or labeled by Silver Star Brands, Vitality Works. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health care professional before use.

PURPOSE

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GOUT CALM 
antimonium crudum, berberis vulgaris, lithium carbonicum spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68703-218
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LITHIUM CARBONATE (UNII: 2BMD2GNA4V) (LITHIUM CATION - UNII:8H8Z5UER66)	LITHIUM CARBONATE	6 [hp_C]  in 59 mL
BERBERIS VULGARIS FRUIT (UNII: 6XEF22AHC3) (BERBERIS VULGARIS FRUIT - UNII:6XEF22AHC3)	BERBERIS VULGARIS FRUIT	30 [hp_C]  in 59 mL
ANTIMONY TRISULFIDE (UNII: F79059A38U) (ANTIMONY TRISULFIDE - UNII:F79059A38U)	ANTIMONY TRISULFIDE	6 [hp_C]  in 59 mL

Inactive Ingredients
Ingredient Name	Strength
CELERY SEED OIL (UNII: 8MBL58728K)
BLACK PEPPER OIL (UNII: U17J84S19Z)
GRAPE SEED OIL (UNII: 930MLC8XGG)
BASIL OIL (UNII: Z129UMU8LE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68703-218-02	59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	01/14/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		01/14/2019

Labeler - Silver Star Brands (006070379)

Registrant - Silver Star Brands (006070379)

Establishment
Name	Address	ID/FEI	Business Operations
Vitality Works		137752817	manufacture(68703-218)