Label: PLEO FORM- formic acid solution/ drops

  • Category: HUMAN OTC DRUG LABEL

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 May 23, 2012

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  • PURPOSE

    Homeopathic
    Medicine

    The original
    SANUM®
    brand remedies

  • Indications

    For temporary relief of joint pain.

  • ACTIVE INGREDIENT

    INGREDIENTS

    30 mL contains: Acidum formicicum 6X, 12X, 30X, 200X in a base of purified water, ethanol (50.6%).

  • Tamper Evident

    Do not use this product if tamper-evident seal on base of bottle cap is missing or broken.

  • DOSAGE

    1-3 × daily 5-20 drops.

  • WARNING

    If symptoms persist more than a few days, contact a licensed practitioner.

    As with any drug, if you are pregnant or nursing a baby, seek the advice of health care professional before using this product.

    Keep this and all other medications out of the reach of children. Incase of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

  • STORAGE AND HANDLING

    Protect from light and heat.

  • SPL UNCLASSIFIED SECTION

    Manufactured by:
    SANUM-Kehlbeck
    GmbH & Co. KG,
    Hoya, Germany

    Distributed by:
    SANUM USA Corp.,
    1465 Salter Road,
    Ferndale, WA 98248

  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

    Pleo®Form

    DROPS 6X,
    12X, 30X, 200X
    Homeopathic
    Medicine

    The original
    SANUM®
    brand remedies

    Indications:
    For temporary relief
    of joint pain.

    1 fl oz
    (30 mL)

    Principal Display Panel - 30 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    PLEO FORM 
    formic acid solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60681-0114
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    formic acid (UNII: 0YIW783RG1) (formic acid - UNII:0YIW783RG1) formic acid200 [hp_X]  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    alcohol (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60681-0114-31 in 1 CARTON
    130 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved homeopathic12/09/2004
    Labeler - Sanum Kehlbeck GmbH & Co. KG (318386133)
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