Label: PLEO SAN STAPH- staphylococcus aureus liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 60681-1285-1, 60681-1285-2 - 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 November 11, 2011
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- PURPOSE
- 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 Vial Carton
1285-1
Pleo® San STAPH
PORTABLE SIPS 5XOral Homeopathic Medicine
The original
SANUM®
brand remediesINDICATIONS: For temporary relief of
acne.DIRECTIONS FOR USE: Snap off top
portion of sipping container. Insert glass
sipping straw.DOSAGE: 1-3 × weekly 1 sip
INGREDIENTS: 1 mL contains Staphylo-
coccus aureus 5X, in a base of purified
saline solution.Tamper Evident: Do not use this product
if the glass vial is broken.ORIGINAL ENDERLEIN
convenient, disposable
single dose containers10 doses, each 1 mL
(.03 fl oz)Rev. 09/2010
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INGREDIENTS AND APPEARANCE
PLEO SAN STAPH
staphylococcus aureus liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60681-1285 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength staphylococcus aureus (UNII: O478WX4004) (staphylococcus aureus - UNII:O478WX4004) staphylococcus aureus 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:60681-1285-1 10 in 1 CARTON 1 1 mL in 1 VIAL, GLASS 2 NDC:60681-1285-2 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 11/30/2006 Labeler - Sanum Kehlbeck GmbH & Co. KG (318386133)