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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated March 4, 2023

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  • 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

    Nail Fungus Relief cartonNail Fungus Relief lable

  • INGREDIENTS AND APPEARANCE
    GOUT CALM 
    antimonium crudum, berberis vulgaris, lithium carbonicum spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68703-218
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ANTIMONY TRISULFIDE (UNII: F79059A38U) (ANTIMONY TRISULFIDE - UNII:F79059A38U) ANTIMONY TRISULFIDE6 [hp_C]  in 59 mL
    BERBERIS VULGARIS FRUIT (UNII: 6XEF22AHC3) (BERBERIS VULGARIS FRUIT - UNII:6XEF22AHC3) BERBERIS VULGARIS FRUIT30 [hp_C]  in 59 mL
    LITHIUM CARBONATE (UNII: 2BMD2GNA4V) (LITHIUM CATION - UNII:8H8Z5UER66) LITHIUM CARBONATE6 [hp_C]  in 59 mL
    Inactive Ingredients
    Ingredient NameStrength
    BLACK PEPPER OIL (UNII: U17J84S19Z)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    BASIL OIL (UNII: Z129UMU8LE)  
    CELERY SEED OIL (UNII: 8MBL58728K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68703-218-0259 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product01/14/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/14/2019
    Labeler - Silver Star Brands (006070379)
    Registrant - Silver Star Brands (006070379)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vitality Works137752817manufacture(68703-218)
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