Label: PLEO FORM- formic acid

  • NDC Code(s): 60681-0115-1, 60681-0115-2
  • Packager: Sanum Kehlbeck GmbH & Co. KG
  • 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 November 20, 2009

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Oral Homeopathic Medicine

    50 doses, each 2 mL
    (.06 fl oz)

    Close
  • INDICATIONS

    For temporary relief of joint pain.

    Close
  • DIRECTIONS FOR USE

    Snap off top portion of sipping container. Insert glass sipping straw.

    Close
  • DOSAGE

    1 SIP, 1–2 times weekly.

    Close
  • INGREDIENTS

    2 mL contains Acidum formicicum 6X, 12X, 30X, 200X, in a base of purified saline solution.

    Close
  • 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 a health care professional before using this product.

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

    Protect from light and heat.

    Tamper Evident

    Do not use this product if the glass vial is broken or if imprinted security strip on carton is torn.

    Close
  • SPL UNCLASSIFIED SECTION

    Made in Germany

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

    Manufactured By:
    Sanum-Kehlbeck GmbH & Co. KG

    Rev. 04/2007

    Close
  • PRINCIPAL DISPLAY PANEL - 2 mL Carton

    0115-2

    Pleo™ Form
    PORTABLE SIPS
    6X, 12X, 30X, 200X

    Oral Homeopathic Medicine

    INDICATIONS: For temporary relief of joint
    pain.

    DIRECTIONS FOR USE: Snap off top
    portion of sipping container. Insert glass
    sipping straw.

    DOSAGE: 1 SIP, 1–2 times weekly.

    INGREDIENTS: 2 mL contains Acidum
    formicicum 6X, 12X, 30X, 200X, in a base
    of purified saline solution.

    convenient, disposable
    single dose containers

    50 doses, each 2 mL
    (.06 fl oz)

    Rev. 04/2007
    303INPASE50US704

    PRINCIPAL DISPLAY PANEL - 2 mL Carton
    Close
  • INGREDIENTS AND APPEARANCE
    PLEO FORM 
    formic acid kit
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:60681-0115
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:60681-0115-1 10 in 1 CARTON
    1 1 in 1 VIAL, GLASS
    2 NDC:60681-0115-2 50 in 1 CARTON
    2 1 in 1 VIAL, GLASS
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1
    Part 2
    Part 3
    Part 4
    Part 1 of 4
    FORMIC ACID 
    formic acid liquid
    Product Information
    Item Code (Source) NDC:60681-0115
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    formic acid (UNII: 0YIW783RG1) (formic acid - UNII:0YIW783RG1) formic acid 6 [hp_X]  in 2 mL
    Inactive Ingredients
    Ingredient Name Strength
    water (UNII: 059QF0KO0R)  
    sodium chloride (UNII: 451W47IQ8X)  
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED HOMEOPATHIC 01/19/1998
    Part 2 of 4
    FORMIC ACID 
    formic acid liquid
    Product Information
    Item Code (Source) NDC:60681-0115
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    formic acid (UNII: 0YIW783RG1) (formic acid - UNII:0YIW783RG1) formic acid 12 [hp_X]  in 2 mL
    Inactive Ingredients
    Ingredient Name Strength
    water (UNII: 059QF0KO0R)  
    sodium chloride (UNII: 451W47IQ8X)  
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED HOMEOPATHIC 01/19/1998
    Part 3 of 4
    FORMIC ACID 
    formic acid liquid
    Product Information
    Item Code (Source) NDC:60681-0115
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    formic acid (UNII: 0YIW783RG1) (formic acid - UNII:0YIW783RG1) formic acid 30 [hp_X]  in 2 mL
    Inactive Ingredients
    Ingredient Name Strength
    water (UNII: 059QF0KO0R)  
    sodium chloride (UNII: 451W47IQ8X)  
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED HOMEOPATHIC 01/19/1998
    Part 4 of 4
    FORMIC ACID 
    formic acid liquid
    Product Information
    Item Code (Source) NDC:60681-0115
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    formic acid (UNII: 0YIW783RG1) (formic acid - UNII:0YIW783RG1) formic acid 200 [hp_X]  in 2 mL
    Inactive Ingredients
    Ingredient Name Strength
    water (UNII: 059QF0KO0R)  
    sodium chloride (UNII: 451W47IQ8X)  
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED HOMEOPATHIC 01/19/1998
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED HOMEOPATHIC 01/19/1998
    Labeler - Sanum Kehlbeck GmbH & Co. KG (318386133)
    Close