Label: PLEO FORM- formic acid kit
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Contains inactivated NDC Code(s)
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.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- INDICATIONS
- DIRECTIONS FOR USE
- DOSAGE
- INGREDIENTS
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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.
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - 2 mL Carton
0115-2
Pleo™ Form
PORTABLE SIPS
6X, 12X, 30X, 200XOral 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 containers50 doses, each 2 mL
(.06 fl oz)Rev. 04/2007
303INPASE50US704
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INGREDIENTS AND APPEARANCE
PLEO FORM
formic acid kitProduct 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 2 Part 2 2 Part 3 2 Part 4 2 Part 1 of 4 FORMIC ACID
formic acid liquidProduct 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 liquidProduct 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 liquidProduct 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 liquidProduct 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)