Label: FIRMUSAN- bacillus firmus solution/ drops

  • 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 April 30, 2024

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  • Indications

    For joint and serous membrane inflammation

    Purpose

    Relieves symptoms of joint and serous membrane inflammation

  • Dosage

    drop 2-5 drops into the mouth, three times weekly

  • Active ingredients

    Bacillus firmus 6X

    Inactive ingeredients

    purified water, 0.09 g sodium chloride, 0.01 g potassium sorbate

  • Warnings

    If pregnant or breast-feeding, ask a health professional before use.
    ______________________________
    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.
    ______________________________
    When using this product
    ▪ do not use more than directed
    ______________________________
    If symptoms persist more than 5 days, contact a licensed practitioner.
    ______________________________
    Tamper Evident: Do not use product if tamper evident strip is broken. To report adverse events, contact MEDsan Inc. at 1-855-462-6334.

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222

  • Liability statement

    These statements or claims are based upon traditional homeopathic practice. They have not been reviewed by the Food & Drug Administration

  • SPL UNCLASSIFIED SECTION

    Manufactured in the USA for:
    sanPharmacy Inc.
    350 Fifth Avenue STE 5220
    New York NY 10118-5220

  • STORAGE AND HANDLING

    protect from light and heat▪once opened do not use for more than 2 weeks

  • PRINCIPAL DISPLAY PANEL

    Outer-PackageInner-Package FirmuSAN

    Homeopathic Medicine

    For joint and serous membrane inflammation

    Oral Drops

    0.34 FL OZ (10 ml)

    sanPharmacy

    biological health solutions

  • INGREDIENTS AND APPEARANCE
    FIRMUSAN 
    bacillus firmus solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73479-016
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACILLUS FIRMUS (UNII: D6U864H4DT) (BACILLUS FIRMUS - UNII:D6U864H4DT) BACILLUS FIRMUS6 [hp_X]  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.09 g  in 10 mL
    WATER (UNII: 059QF0KO0R) 10 mL  in 10 mL
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4) 0.01 g  in 10 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73479-016-041 in 1 CARTON04/29/2024
    110 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/29/2024
    Labeler - sanPharmacy Inc. (117235152)
    Establishment
    NameAddressID/FEIBusiness Operations
    MEDsan Inc.004326784manufacture(73479-016)
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