NOTASAN- penicillium chrysogenum var. chrysogenum cream
sanPharma GmbH

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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NotaSAN

Penicillium chrysogenum (syn. Penicillium notatum) 3X in amphiphilic cream base.

Indication

Dermal inflammation and skin irritation.

No preservatives added.

Ingredients

100g contain: 10g Active ingredient-dilution (Penicillium chrysogenum 3X according to HAB regulation 5a with purified water); Inacitve ingredients: 35g Purified Water, 22,31g Petrolatum, 11,25g Propylene Glycol, 6,56g Caprylic/Capric Triglyceride, 6,13g PEG-20 Glyceryl Stearate, 5,25g Cetyl Alcohol, 3,5g Glyceryl Monostearate 60.

Dosage

Apply sparsely to the affected area 3× daily unless otherwise indicated by your practitioner.

For external use only.

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.

Protect from light and heat.

Tamper Evident

Do not use product if tamper evident strip is broken. To report adverse events, contact Bio-Resource at 707/664-9023 or bioresource2@prodigy.net

Distributed By: BioResource Inc., Cotati CA 94931

PRINCIPAL DISPLAY PANEL - 150 ml Bottle Label

notaSAN cream

anti-inflammatory

sanPharma ®
biological health solutions

PRINCIPAL DISPLAY PANEL - 150 ml Bottle Label

NOTASAN
penicillium chrysogenum var. chrysogenum cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:64232-103
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (UNII: 3Y1PE1GCIG) (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM - UNII:3Y1PE1GCIG)	PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM	3 [hp_X] in 150 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
PETROLATUM (UNII: 4T6H12BN9U)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PEG-20 GLYCERYL STEARATE (UNII: MJV0165YY8)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:64232-103-17	150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	01/07/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		01/07/2017	12/10/2019

Labeler - sanPharma GmbH (341409153)

Name	Address	ID/FEI	Business Operations
Establishment
sanPharma GmbH		341409153	manufacture(64232-103) , label(64232-103)

Revised: 12/2019

Document Id: 99581b4d-9eb0-41b0-e053-2a95a90a43eb

Set id: 64d01559-28a5-42cd-9a3f-35790786364e

Version: 4

Effective Time: 20191210

sanPharma GmbH