Label: PLEO SAN STAPH- staphylococcus aureus liquid
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.
Updated November 11, 2011
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- DIRECTIONS FOR USE
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.
- SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL - 1 mL Vial Carton
Pleo® San STAPH
PORTABLE SIPS 5X
Oral Homeopathic Medicine
INDICATIONS: For temporary relief of
DIRECTIONS FOR USE: Snap off top
portion of sipping container. Insert glass
DOSAGE: 1-3 × weekly 1 sip
INGREDIENTS: 1 mL contains Staphylo-
coccus aureus 5X, in a base of purified
Tamper Evident: Do not use this product
if the glass vial is broken.
single dose containers
10 doses, each 1 mL
(.03 fl oz)
INGREDIENTS AND APPEARANCE
PLEO SAN STAPH
staphylococcus aureus liquid
Product 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)