Pleo Usnea: Homeopathic Product Information

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.

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
(click image for full-size original)
PLEO USNEA
usnea barbata solution/ drops
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:60681-5101
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
usnea barbata (usnea barbata) usnea barbata 1 [HP_X] in 30 mL
Inactive Ingredients
Ingredient Name Strength
water
Alcohol
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60681-5101-3 1 BOTTLE, DROPPER (BOTTLE) in 1 CARTON contains a BOTTLE, DROPPER
1 30 mL in 1 BOTTLE, DROPPER This package is contained within the CARTON (60681-5101-3)
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)

Revised: 10/2009 Sanum Kehlbeck GmbH & Co. KG

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