![PLEO SANUVIS (LACTIC ACID, L-) KIT [SANUM KEHLBECK GMBH & CO. KG]](https://medic.hrt.org//dailymed/images/9cae271c-0cd1-482b-901e-e75e9a60e76a/pleo-sanuvis-01.jpg)
- 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)