Label: SAPONARIA OFFICINALIS- saponaria officinalis root pellet

  • 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 November 14, 2023

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  • Active Ingredients

    Saponaria officinalis 6X

    (**contains 0.443 mg of the active ingredient per pellet)

  • PURPOSE

  • Use

    Skin rash with itching*

  • Warnings

    Stop use and ask a doctor if

    symptoms persist for more than 3 days or worsen.

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

  • Directions

    Adults and children: At the onset of symptoms, dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved or as directed by a doctor.

  • Other information

    Do not use if pellet dispenser seal is broken.
    contains approx. 80 pellets

  • Inactive ingredients

    lactose, sucrose

  • Questions, Comments?

    1-800-BOIRON-1
    Newtown Square, PA 19073-3267
    info@boironusa.com

  • *

    Do not use if pellet dispenser seal is broken.
    Contains approx 80 pellets.
    How to dispense pellets? Turn tube upside down. Twist until 5 pellets are dispensed into cap. Carefully remove the cap and use it to pour pellets under the tongue.
    *CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.
    **C,K,CK, and X are homeopathic dilutions: see BoironUSA.com/info for details.

  • Principle Display Panel - Saponaria officinalis HPUS 6X

    labelimage

  • INGREDIENTS AND APPEARANCE
    SAPONARIA OFFICINALIS 
    saponaria officinalis root pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0220-4562
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SAPONARIA OFFICINALIS ROOT (UNII: RI2K1BMA8B) (SAPONARIA OFFICINALIS ROOT - UNII:RI2K1BMA8B) SAPONARIA OFFICINALIS ROOT6 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    LACTOSE (UNII: J2B2A4N98G)  
    Product Characteristics
    ColorwhiteScore    
    ShapeROUNDSize4mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0220-4562-4180 in 1 TUBE; Type 0: Not a Combination Product03/03/1983
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/03/1983
    Labeler - Laboratoires Boiron (282560473)
    Registrant - Boiron Inc. (014892269)
    Establishment
    NameAddressID/FEIBusiness Operations
    Boiron282560473manufacture(0220-4562)
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