Label: HENDEL PERIODONTAL AND TOOTH PAIN RELIEF- sodium borate, tribasic calcium phosphate, mercurius solubilis, and silicon dioxide tablet

  • 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 August 22, 2022

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  • WARNINGS

    WARNINGS: If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Stop use and ask doctor if symptoms do not improve in 7 days or if swelling or fever develops or if irritation, pain or redness persist or worsens.

    Do not use if sensitivity to Periodontal & Tooth Pain Relief or any of its ingredients exists. In case of accidental overdose, contact a Poison Control Center immediately.

    PURPOSE

    Periodontal & Tooth Pain Relief

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • USES

    For the temporary relief of:

    • Sore gums
    • Toothache
    • Bad breath

  • ACTIVE INGREDIENTS

    Active Ingredients:

    Each tablet contains equal parts of Borax 8X; Calcarea phosphorica 12X; Mercurius solubilis 12X; Silicea 12X

  • INACTIVE INGREDIENTS

    Inactive Ingredients:

    Lactose, Magnesium stearate

  • DIRECTIONS

    Dosage: Adults 18 and over: 1 tablet sublingually or dissolved completely in mouth 2 to 3 times per day or as directed by a physician.

  • PRINCIPAL DISPLAY PANEL

    image descriptionHendel Periodontal and Tooth Pain Relief

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  • INGREDIENTS AND APPEARANCE
    HENDEL PERIODONTAL AND TOOTH PAIN RELIEF 
    sodium borate, tribasic calcium phosphate, mercurius solubilis, and silicon dioxide tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62795-1133
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM BORATE (UNII: 91MBZ8H3QO) (BORATE ION - UNII:44OAE30D22) SODIUM BORATE8 [hp_X]
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION12 [hp_X]
    MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2) MERCURIUS SOLUBILIS12 [hp_X]
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE12 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code Leafman
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62795-1133-2100 in 1 BOTTLE; Type 0: Not a Combination Product08/01/201801/31/2027
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/01/201801/31/2027
    Labeler - MediNatura Inc (079324099)
    Establishment
    NameAddressID/FEIBusiness Operations
    MediNatura Inc102783016manufacture(62795-1133)
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