Label: PLEO SANUVIS- lactic acid, l-

  • 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.

  • SPL UNCLASSIFIED SECTION

    Homeopathic Digestive Aid Lactic Acid

    3.38 fl oz
    (100 mL)

    Close
  • 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.

    Close
  • 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.

    Close
  • DOSAGE

    1-3 × daily 5-20 drops.

    Close
  • 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.

    Close
  • STORAGE AND HANDLING

    Protect from light and heat.

    Close
  • 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. 12/2007

    Close
  • 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
    Close
  • INGREDIENTS AND APPEARANCE
    PLEO SANUVIS 
    lactic acid, l- kit
    Product 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- solution
    Product 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- solution
    Product 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- solution
    Product 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- solution
    Product 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- solution
    Product 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)
    Close