Pleo Sancom: Homeopathic Product Information

PLEO SANCOM- mucor racemosus and aspergillus niger var. niger 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 Medicine

0.34 fl oz (10 mL)

Indications

For temporary relief of sore throat.

INGREDIENTS

10 mL contains 5 mL Mucor racemosus 5X, 5 mL Aspergillus niger 5X in a base of purified water.

Tamper Evident

Do not use this product if tamper-evident seal on base of bottle cap is missing or broken or if imprinted security strip on carton is torn.

DOSAGE

5–10 drops, once daily, before mealtime.

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 other 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. 12/2006

PRINCIPAL DISPLAY PANEL — 10 mL Label

Pleo™ Sancom DROPS 5X

Homeopathic Medicine

Indications: For temporary relief of sore throat.

0.34 fl oz (10 mL)

DOSAGE: 5–10 drops, once daily, before mealtime. 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: 5 mL Mucor racemosus
5X, 5 mL Aspergillus niger 5X in a base of purified water.
Rev. 06/2009

Principal Display Panel -- 10 mL Label
(click image for full-size original)
PLEO SANCOM
mucor racemosus and aspergillus niger var. niger solution/ drops
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:60681-3401
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
mucor racemosus (mucor racemosus) mucor racemosus 5 [hp_X] in 10 mL
aspergillus niger var. niger (aspergillus niger var. niger) aspergillus niger var. niger 5 [hp_X] in 10 mL
Inactive Ingredients
Ingredient Name Strength
water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60681-3401-1 1 BOTTLE, DROPPER (BOTTLE) in 1 CARTON contains a BOTTLE, DROPPER
1 10 mL in 1 BOTTLE, DROPPER This package is contained within the CARTON (60681-3401-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved homeopathic 12/19/1996
Labeler — Sanum Kehlbeck GmbH & Co. KG (318386133)

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

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