PLEO SAN ACNE- propionibacterium acnes 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™ San
ACNE
DROPS 6X

Homeopathic Medicine

0.34 fl oz
(10 mL)

Indications

For temporary relief of acne.

INGREDIENTS

10 mL Propionibacterium acnes 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 or if imprinted security strip on carton is torn.

DOSAGE

1-2 × daily 5-10 drops.

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.

Made in Germany

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

Manufactured By:
Sanum-Kehlbeck,
GmbH & Co. KG

Rev. 12/2007

PRINCIPAL DISPLAY PANEL - 10 mL Label

Pleo™ San ACNE DROPS 6X

Homeopathic Medicine

Indications: For temporary relief of acne.

0.34 fl oz (10 mL)

DOSAGE: 1–2 × daily 5–10 drops. 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 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: 10 mL Propionibacterium acnes
6X in a base of purified water.
Rev. 06/2009

Principal Display Panel - 10 mL Label
PLEO SAN ACNE 
propionibacterium acnes solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60681-3601
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
propionibacterium acnes (UNII: TRZ1AA965O) (propionibacterium acnes - UNII:TRZ1AA965O) propionibacterium acnes6 [hp_X]  in 10 mL
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60681-3601-11 in 1 CARTON
110 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved homeopathic12/19/1996
Labeler - Sanum Kehlbeck GmbH & Co. KG (318386133)

Revised: 8/2011
Document Id: cb472270-9e6f-49a8-b63b-ea0c803b2092
Set id: 4389d5e9-0b49-4319-876e-cd0f6b7327c3
Version: 2
Effective Time: 20110801
 
Sanum Kehlbeck GmbH & Co. KG