PLEO SANUVIS- lactic acid, l- 
Sanum Kehlbeck GmbH & Co. KG

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.

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Pleo™ Sanuvis

Homeopathic Digestive Aid Lactic Acid

3.38 fl oz
(100 mL)

INGREDIENTS

100mL solution contains L-Lactic acid (4X, 6X, 12X, 30X, 200X, in equal amounts), in a base of purified water, alcohol 12.4% by volume.

Tamper evident

Do not use this product if tamper-evident seal on base of bottle cap is missing or broken or if imprinted security strip on carton is torn.

DOSAGE

1-3 × daily 5-20 drops.

WARNING

If symptoms persist more than a few days, contact a licensed practitioner. As with any other 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.

Made in Germany

Distributed by:
SANUM USA Corp.
1465 Slater Road
Ferndale, WA 98248

Manufactured By:
Sanum-Kehlbeck
GmbH & Co. KG

Rev. 12/2007

PRINCIPAL DISPLAY PANEL - 100 mL Label

Pleo™ Sanuvis

HOMEOPATHIC DIGESTIVE AID
Lactic Acid

3.38 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

Principal Display Panel - 100 mL Label
PLEO SANUVIS 
lactic acid, l- kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60681-6300
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60681-6300-11 in 1 CARTON
11 in 1 BOTTLE, DROPPER
Quantity of Parts
Part #Package QuantityTotal 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- solution
Product Information
Item Code (Source)NDC:60681-6300
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
lactic acid, l- (UNII: F9S9FFU82N) (lactic acid, l- - UNII:F9S9FFU82N) lactic acid, l-4 [hp_X]  in 100 mL
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
alcohol (UNII: 3K9958V90M)  
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved homeopathic02/19/1997
Part 2 of 5
LACTIC ACID, L- 
lactic acid, l- solution
Product Information
Item Code (Source)NDC:60681-6300
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
lactic acid, l- (UNII: F9S9FFU82N) (lactic acid, l- - UNII:F9S9FFU82N) lactic acid, l-6 [hp_X]  in 100 mL
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
alcohol (UNII: 3K9958V90M)  
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved homeopathic02/19/1997
Part 3 of 5
LACTIC ACID, L- 
lactic acid, l- solution
Product Information
Item Code (Source)NDC:60681-6300
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
lactic acid, l- (UNII: F9S9FFU82N) (lactic acid, l- - UNII:F9S9FFU82N) lactic acid, l-12 [hp_X]  in 100 mL
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
alcohol (UNII: 3K9958V90M)  
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved homeopathic02/19/1997
Part 4 of 5
LACTIC ACID, L- 
lactic acid, l- solution
Product Information
Item Code (Source)NDC:60681-6300
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
lactic acid, l- (UNII: F9S9FFU82N) (lactic acid, l- - UNII:F9S9FFU82N) lactic acid, l-30 [hp_X]  in 100 mL
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
alcohol (UNII: 3K9958V90M)  
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved homeopathic02/19/1997
Part 5 of 5
LACTIC ACID, L- 
lactic acid, l- solution
Product Information
Item Code (Source)NDC:60681-6300
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
lactic acid, l- (UNII: F9S9FFU82N) (lactic acid, l- - UNII:F9S9FFU82N) lactic acid, l-200 [hp_X]  in 100 mL
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
alcohol (UNII: 3K9958V90M)  
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved homeopathic02/19/1997
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved homeopathic02/19/1997
Labeler - Sanum Kehlbeck GmbH & Co. KG (318386133)

Revised: 10/2009
Document Id: 07979e63-5919-4479-a97b-287e56e0b182
Set id: 9cae271c-0cd1-482b-901e-e75e9a60e76a
Version: 1
Effective Time: 20091007
 
Sanum Kehlbeck GmbH & Co. KG