PLEO UT- bacillus subtilis 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® Ut
DROPS 6X

Homeopathic Analgesic Medicine

0.17 fl oz
(5 mL)

DOSAGE

1–3 times weekly 2–5 drops 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.

INGREDIENTS

5 mL Bacillus subtilis 6X, 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.

Manufactured by:
SANUM-Kehlbeck
GmbH & Co. KG,
Hoya, Germany

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

PRINCIPAL DISPLAY PANEL - 5 mL Bottle Carton

Pleo® Ut

DROPS 6X
Homeopathic
Analgesic
Medicine

The original
SANUM®
brand remedies

Indications: For
temporary pain
relief of swollen
lymph glands.

0.17 fl oz
(5 mL)

Principal Display Panel - 5 mL Bottle Carton
PLEO UT 
bacillus subtilis solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60681-5301
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
bacillus subtilis (UNII: 8CF93KW41W) (bacillus subtilis - UNII:8CF93KW41W) bacillus subtilis6 [hp_X]  in 5 mL
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60681-5301-21 in 1 CARTON
15 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved homeopathic03/19/1996
Labeler - Sanum Kehlbeck GmbH & Co. KG (318386133)

Revised: 3/2012
Document Id: f8f9ef39-0eb5-4596-bd05-4b8b37facc3b
Set id: 50d6865b-689a-4f81-b464-08423096f31a
Version: 2
Effective Time: 20120309
 
Sanum Kehlbeck GmbH & Co. KG