Label: PLEO USNEA- usnea barbata solution/ drops
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Contains inactivated NDC Code(s)
NDC Code(s): 60681-5101-3 - 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 October 9, 2009
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- SPL UNCLASSIFIED SECTION
- Indications
- INGREDIENTS
- Tamper Evident
- DOSAGE
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WARNING
If symptoms persist more than a few days, contact a licensed practitioner. As with any other drugs, 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 - 30 mL Label
Pleo™ Usnea DROPS 1X
Homeopathic Analgesic Medicine
Indications: For temporary relief of headaches.
1 fl oz (30 mL)
DOSAGE: Acute: 5 drops, every 1/2 to 1 hour; Chronic: 5 drops, 1–3 times daily. 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: 30 mL contains: Usnea barbata 1X in a base
of purified water, ethanol (70 %).
Rev. 06/2009
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INGREDIENTS AND APPEARANCE
PLEO USNEA
usnea barbata solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60681-5101 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength usnea barbata (UNII: D6DVA9TCAP) (usnea barbata - UNII:D6DVA9TCAP) usnea barbata 1 [HP_X] in 30 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) Alcohol (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60681-5101-3 1 in 1 CARTON 1 30 mL in 1 BOTTLE, DROPPER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved homeopathic 12/13/1996 Labeler - Sanum Kehlbeck GmbH & Co. KG (318386133)