PLEO NIG- 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.

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Pleo™ Nig
PORTABLE SIPS 6X

Oral Homeopathic Medicine

50 doses, each 1 mL
(.03 fl oz)

INDICATIONS

For temporary relief of external itching and soreness in the urogenital region.

DIRECTIONS FOR USE

Snap off top portion of sipping container. Insert glass sipping straw.

DOSAGE

1 SIP, twice weekly.

INGREDIENTS

1 mL contains Aspergillus niger 6X, in a base of purified saline solution.

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 the glass vial is broken or if imprinted security strip on carton is torn.

Made in Germany

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

Manufactured By:
Sanum-Kehlbeck GmbH & Co. KG

Rev. 09/2002

PRINCIPAL DISPLAY PANEL - 1 mL Carton

2107-2

Pleo™ Nig
PORTABLE SIPS 6X

Oral Homeopathic Medicine

INDICATIONS: For temporary relief of ex-
ternal itching and soreness in the urogeni-
tal region.

DIRECTIONS FOR USE: Snap off top
portion of sipping container. Insert glass
sipping straw.

DOSAGE: 1 SIP, twice weekly.

INGREDIENTS: 1 mL contains Aspergil-
lus niger 6X, in a base of purified saline
solution.

convenient, disposable
single dose containers

50 doses, each 1 mL
(.03 fl oz)

Rev. 09/2002

PRINCIPAL DISPLAY PANEL - 1 mL Carton
PLEO NIG 
aspergillus niger var. niger solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60681-2107
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
aspergillus niger var. niger (UNII: 9IOA40ANG6) (aspergillus niger var. niger - UNII:9IOA40ANG6) aspergillus niger var. niger6 [HP_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
sodium chloride (UNII: 451W47IQ8X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60681-2107-110 in 1 CARTON
11 mL in 1 VIAL, GLASS
2NDC:60681-2107-250 in 1 CARTON
21 mL in 1 VIAL, GLASS
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved homeopathic03/19/1997
Labeler - Sanum Kehlbeck GmbH & Co. KG (318386133)

Revised: 10/2009
Document Id: 59218acd-3120-4361-9da6-1380a371c9fb
Set id: 6ef003a3-efc9-4d78-9e3c-051887a65412
Version: 1
Effective Time: 20091008
 
Sanum Kehlbeck GmbH & Co. KG