PLEO SANUVIS- lactic acid, l- kit

Pleo Sanuvis by

Drug Labeling and Warnings

Pleo Sanuvis 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

Digestive Aid.

DIRECTIONS FOR USE

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

DOSAGE

1 SIP, 1–3 times weekly.

INGREDIENTS

2 mL contains L(+)-Lactic acid 4X, 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. 09/2000

PRINCIPAL DISPLAY PANEL - 2 mL Carton

6302-2

Pleo™ Sanuvis
PORTABLE SIPS
4X, 6X, 12X, 30X, 200X

Oral Homeopathic Medicine

INDICATIONS: Digestive Aid.

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

DOSAGE: 1 SIP, 1–3 times weekly.

INGREDIENTS: 2 mL contains L(+)-Lac-
tic acid 4X, 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. 09/2000

INGREDIENTS AND APPEARANCE

PLEO SANUVIS 
lactic acid, l- kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60681-6302

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60681-6302-1	10 in 1 CARTON
1		1 in 1 VIAL, GLASS
2	NDC: 60681-6302-2	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 5		2

Part 1 of 5

LACTIC ACID, L- 
lactic acid, l- liquid

Product Information
Item Code (Source)	NDC: 60681-6302
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
lactic acid, l- (UNII: F9S9FFU82N) (lactic acid, l- - UNII:F9S9FFU82N)	lactic acid, l-	4 [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		05/24/2004

Part 2 of 5

LACTIC ACID, L- 
lactic acid, l- liquid

Product Information
Item Code (Source)	NDC: 60681-6302
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
lactic acid, l- (UNII: F9S9FFU82N) (lactic acid, l- - UNII:F9S9FFU82N)	lactic acid, l-	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		05/24/2004

Part 3 of 5

LACTIC ACID, L- 
lactic acid, l- liquid

Product Information
Item Code (Source)	NDC: 60681-6302
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
lactic acid, l- (UNII: F9S9FFU82N) (lactic acid, l- - UNII:F9S9FFU82N)	lactic acid, l-	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		05/24/2004

Part 4 of 5

LACTIC ACID, L- 
lactic acid, l- liquid

Product Information
Item Code (Source)	NDC: 60681-6302
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
lactic acid, l- (UNII: F9S9FFU82N) (lactic acid, l- - UNII:F9S9FFU82N)	lactic acid, l-	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		05/24/2004

Part 5 of 5

LACTIC ACID, L- 
lactic acid, l- liquid

Product Information
Item Code (Source)	NDC: 60681-6302
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
lactic acid, l- (UNII: F9S9FFU82N) (lactic acid, l- - UNII:F9S9FFU82N)	lactic acid, l-	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		05/24/2004

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED HOMEOPATHIC		05/24/2004

Labeler - Sanum Kehlbeck GmbH & Co. KG (318386133)