PLEO FORM- formic acid kit

Pleo Form by

Drug Labeling and Warnings

Pleo Form by is a Homeopathic medication manufactured, distributed, or labeled by Sanum Kehlbeck GmbH & Co. KG. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Oral Homeopathic Medicine

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

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.

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.

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

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

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		2
Part 2		2
Part 3		2
Part 4		2

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)