Label: PLEO SANUVIS- lactic acid, l- kit
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Contains inactivated NDC Code(s)
NDC Code(s): 60681-6300-1 - 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 October 7, 2009
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- INGREDIENTS
- Tamper evident
- DOSAGE
- WARNING
- STORAGE AND HANDLING
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - 100 mL Label
Pleo™ Sanuvis
HOMEOPATHIC DIGESTIVE AID
Lactic Acid3.38 fl oz (100 mL)
DOSAGE: 1–3 x daily 5–20 drops. 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 tamper-evident seal
on base of bottle cap is missing or broken. INGREDIENTS: 100 mL solution contains
L(+)-Lactic acid (4X, 6 X, 12X, 30X, 200X, in equal amounts), water, alcohol 12.4% by
volume.
Rev. 06/2009
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INGREDIENTS AND APPEARANCE
PLEO SANUVIS
lactic acid, l- kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60681-6300 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60681-6300-1 1 in 1 CARTON 1 1 in 1 BOTTLE, DROPPER Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 100 Part 2 100 Part 3 100 Part 4 100 Part 5 100 Part 1 of 5 LACTIC ACID, L-
lactic acid, l- solutionProduct Information Item Code (Source) NDC:60681-6300 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 100 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) alcohol (UNII: 3K9958V90M) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved homeopathic 02/19/1997 Part 2 of 5 LACTIC ACID, L-
lactic acid, l- solutionProduct Information Item Code (Source) NDC:60681-6300 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 100 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) alcohol (UNII: 3K9958V90M) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved homeopathic 02/19/1997 Part 3 of 5 LACTIC ACID, L-
lactic acid, l- solutionProduct Information Item Code (Source) NDC:60681-6300 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 100 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) alcohol (UNII: 3K9958V90M) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved homeopathic 02/19/1997 Part 4 of 5 LACTIC ACID, L-
lactic acid, l- solutionProduct Information Item Code (Source) NDC:60681-6300 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 100 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) alcohol (UNII: 3K9958V90M) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved homeopathic 02/19/1997 Part 5 of 5 LACTIC ACID, L-
lactic acid, l- solutionProduct Information Item Code (Source) NDC:60681-6300 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 100 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) alcohol (UNII: 3K9958V90M) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved homeopathic 02/19/1997 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved homeopathic 02/19/1997 Labeler - Sanum Kehlbeck GmbH & Co. KG (318386133)