Label: PLEO SAN MYC- mycobacterium bovis liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 60681-1205-1, 60681-1205-2 - 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 23, 2009
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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 - 1 mL Carton
1205-2
Pleo™ San MYC
PORTABLE SIPS 5XOral Homeopathic Medicine
INDICATIONS: For temporary relief of dry
and scaly skin.DIRECTIONS FOR USE: Snap off top
portion of sipping container. Insert glass
sipping straw.DOSAGE: 1 SIP, every 1–3 days.
INGREDIENTS: 1 mL contains Mycobac-
terium bovis 5X, in a base of purified sa-
line solution.convenient, disposable
single dose containers50 doses, each 1 mL
(.03 fl oz)Rev. 11/97
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INGREDIENTS AND APPEARANCE
PLEO SAN MYC
mycobacterium bovis liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60681-1205 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength mycobacterium bovis (UNII: XZQ806VFEO) (mycobacterium bovis - UNII:XZQ806VFEO) mycobacterium bovis 5 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength sodium chloride (UNII: 451W47IQ8X) water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60681-1205-1 10 in 1 CARTON 1 1 mL in 1 VIAL, GLASS 2 NDC:60681-1205-2 50 in 1 CARTON 2 1 mL in 1 VIAL, GLASS Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED HOMEOPATHIC 04/21/2004 Labeler - Sanum Kehlbeck GmbH & Co. KG (318386133)