PLEO USNEA- usnea barbata solution/ drops 
Sanum Kehlbeck GmbH & Co. KG

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.

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Pleo™ Usnea
DROPS 1X

Homeopathic Analgesic Medicine

1 fl oz
(30 mL)

Indications

For temporary relief of headaches.

INGREDIENTS

30 mL Usnea barbata 1X in a base of purified water, ethanol (70%).

Tamper Evident

Do not use this product if the tamper evident seat at base of bottle cap is missing or broken.

DOSAGE

Acute: 5 drops, every ½ 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 other drugs, 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.

Made in Germany

Distributed by:
SANUM USA Corp.
1465 Slater Road
Ferndale, WA 98248

Manufactured By:
Sanum-Kehlbeck
GmbH & Co. KG

Rev. 12/2001

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

Principal Display Panel 30 mL Label
PLEO USNEA 
usnea barbata solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60681-5101
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
usnea barbata (UNII: D6DVA9TCAP) (usnea barbata - UNII:D6DVA9TCAP) usnea barbata1 [HP_X]  in 30 mL
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
Alcohol (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60681-5101-31 in 1 CARTON
130 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved homeopathic12/13/1996
Labeler - Sanum Kehlbeck GmbH & Co. KG (318386133)

Revised: 10/2009
Document Id: b17a42a5-eff5-4604-8b6a-69459cc8d4b3
Set id: 9d8fb062-f7a2-41a6-95f6-438b99e25e7e
Version: 1
Effective Time: 20091009
 
Sanum Kehlbeck GmbH & Co. KG