Label: BORAX- sodium borate 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 January 23, 2023

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingedient** (in each pellet)

    Borax 6C HPUS (0.44 mg)

    The letters "HPUS" indicate that the component in this product is offically monographed in the Homeopathic Pharmacopoeia of the United States.

  • PURPOSE

    Purpose*

    Relieves minor canker sore pain or mouth irritations

  • INDICATIONS & USAGE

    Uses*

    temporarily relieves symptoms of canker sores or minor mouth and gum irritations such as:

    • pain
    • soreness
    • discomfort

    Tube- Canker Sores*

  • WARNINGS

  • STOP USE

    Stop use and ask a doctor if

    • sore mouth symptoms do not improve in 3 days
    • irritation, pain, or redness persists or worsens
    • swelling, rash, or fever develops.

    Tube- Stop use and ask a doctor if symptoms persist for more than 3 days or worsen

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breastfeeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case overdose, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    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.

  • SPL UNCLASSIFIED SECTION

    • do not use if glued carton end flaps are open or if pellet dispenser seal is broken
    • contains 0.25 g of sugar per dose

    Canker Sore Relief*

    Pain Soreness Discomfort*

    3 TUBES

    APPROX. 80 PELLETS EACH

    TOTAL 240 PELLETS

    16 DOSES PER TUBE

    Relieves Minor Sores & Irritation from Dentures or Braces*

    Turn tube upside down Twist until 5 pellets are dispensed Remove cap and pour pellets under the tongue

    Tube-

    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.

  • INACTIVE INGREDIENT

    lactose, sucrose

  • QUESTIONS

    1-800-BOIRON-1 (1-800-264-7661),
    BoironUSA.com Info@boiron.com
    Distributed by Boiron, Inc. Newtown Square, PA 19073

  • PRINCIPAL DISPLAY PANEL

    Labellabel

  • INGREDIENTS AND APPEARANCE
    BORAX 
    sodium borate pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0220-0889
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM BORATE (UNII: 91MBZ8H3QO) (BORATE ION - UNII:44OAE30D22) SODIUM BORATE6 [hp_C]  in 6 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    Product Characteristics
    ColorwhiteScore    
    ShapeROUNDSize4mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0220-0889-416 [hp_C] in 1 TUBE; Type 0: Not a Combination Product03/03/1983
    2NDC:0220-0889-433 in 1 BOX05/12/2022
    26 [hp_C] in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/03/1983
    Labeler - Boiron (282560473)
    Registrant - Boiron, Inc. (014892269)
    Establishment
    NameAddressID/FEIBusiness Operations
    Boiron282560473manufacture(0220-0889)