Label: PLEO SANUVIS- lactic acid, l- kit
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Contains inactivated NDC Code(s)
NDC Code(s): 60681-6302-1, 60681-6302-2 - Packager: Sanum Kehlbeck GmbH & Co. KG
- 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 November 20, 2009
If you are a healthcare professional or from the pharmaceutical industry 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
6302-2
Pleo™ Sanuvis
PORTABLE SIPS
4X, 6X, 12X, 30X, 200XOral 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 containers50 doses, each 2 mL
(.06 fl oz)Rev. 09/2000
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INGREDIENTS AND APPEARANCE
PLEO SANUVIS
lactic acid, l- kitProduct 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- liquidProduct 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- liquidProduct 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- liquidProduct 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- liquidProduct 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- liquidProduct 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)