Label: NOTASAN (penicillium notatum- chrysogenum cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

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.

Drug Label Information

Updated May 2, 2024

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  • Indications

    Anti-inflammatory

    Purpose

    Relieves symptoms of dermal inflammation and skin irritation

  • Active ingredients

    Penicillium notatum (chrysogenum) 3X

    Inactive ingeredients

    purified water, petrolatum, propylene Glycol, caprylic/capric triglyceride, PEG-20 glyceryl stearate, cetyl alcohol, glyceryl monostearate 60

  • Dosage

    apply sparesly to the affected area three times daily

  • Warnings

    If pregnant or breast-feeding, ask a health professional before use.
    ______________________________
    Keep out of reach of children. In case of ingestion call Poison Control Center hotline immediately at 1-800-222-1222.
    ______________________________
    For external use only.
    ______________________________
    When using this product
    ▪ do not use more than directed
    ______________________________
    If symptoms persist more than 5 days, contact a licensed practitioner.
    ______________________________
    Tamper Evident: Do not use product if tamper evident strip is broken. To report adverse events, contact MEDsan Inc. at 1-855-462-6334.

    Keep out of reach of children. In case of ingestion call Poison Control Center hotline immediately at 1-800-222-1222

  • Liability statement

    These statements or claims are based upon traditional homeopathic practice. They have not been reviewed by the Food & Drug Administration

  • SPL UNCLASSIFIED SECTION

    Manufactured in the USA for:
    sanPharmacy Inc.
    350 Fifth Avenue STE 5220
    New York NY 10118-5220

  • STORAGE AND HANDLING

    protect from light and heat

  • PRINCIPAL DISPLAY PANEL

    Outer-PackageInner-Package NotaSAN

    Homeopathic Medicine

    Anti-inflammatory

    Cream

    3.38 FL OZ (100 ml)

    sanPharmacy

    biological health solutions

  • INGREDIENTS AND APPEARANCE
    NOTASAN 
    penicillium notatum (chrysogenum) cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73479-031
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (UNII: 3Y1PE1GCIG) (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM - UNII:3Y1PE1GCIG) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM3 [hp_X]  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    PEG-20 GLYCERYL STEARATE (UNII: MJV0165YY8)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73479-031-071 in 1 CARTON04/30/2024
    1100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/30/2024
    Labeler - sanPharmacy Inc. (117235152)
    Establishment
    NameAddressID/FEIBusiness Operations
    MEDsan Inc.004326784manufacture(73479-031)
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