Label: DENTAL PLAK- baptisia tinctoria, calcarea carbonica, carbo vegetabilis, kreosotum, magnesia phosphorica, mercurius vivus, phosphorus, sulphur liquid

  • 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 5, 2014

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  • ACTIVE INGREDIENT

    Drug Facts​__________________________________________________________________________________________________________

    HPUS activeingredients: Baptisia tinctoria, Calcarea carbonica, Carbo vegetabilis, Kreosotum, Magnesia phosphorica, Mercurius vivus, Phosphorus, Sulphur. Equal volumes of each ingredient in 10X, 30X, LM1 potencies.

  • INDICATIONS & USAGE

    Uses a natural aid for the symptoms of coatings on teeth, and minor gum irritations: toothaches, sore or swollen gums, mucus on teeth, throbbing pain in teeth, sensitivity to touch or coldness on teeth.

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Bio-Energetically Enhanced™ pure water, citric acid and potassium sorbate.

  • WARNINGS

    Warnings

    • Stop use and ask your doctor if symptoms persist or worsen.
    • If pregnant or breast-feeding, ask a healthcare professional before use.
  • KEEP OUT OF REACH OF CHILDREN

    • Keep out of reach of children.
  • DOSAGE & ADMINISTRATION

    Directions

    • Initially, depress pump until primed.
    • Spray one dose directly into mouth.
    • Ages 12 and up: 3 sprays 3 times per day.
    • Ages 2-12: 2 sprays 3 times per day
  • OTHER SAFETY INFORMATION

    Tamper resistant for your protection. Use only if safety seal is intact.

  • PURPOSE

    Uses a natural aid for the symptoms of coatings on teeth, and minor gum irritations:

    • toothaches
    • sore or swollen gums
    • mucus on teeth
    • throbbing pain in teeth
    • sensitivity to touch or coldness on teeth
  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    DENTAL PLAK 
    baptisia tinctoria, calcarea carbonica, carbo vegetabilis, kreosotum, magnesia phosphorica, mercurius vivus, phosphorus, sulphur liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57955-1904
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BAPTISIA TINCTORIA ROOT (UNII: 5EF0HWI5WU) (BAPTISIA TINCTORIA ROOT - UNII:5EF0HWI5WU) BAPTISIA TINCTORIA ROOT10   in 59 mL
    OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE10 [hp_X]  in 59 mL
    ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10) ACTIVATED CHARCOAL10 [hp_X]  in 59 mL
    WOOD CREOSOTE (UNII: 3JYG22FD73) (WOOD CREOSOTE - UNII:3JYG22FD73) WOOD CREOSOTE10 [hp_X]  in 59 mL
    MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE10 [hp_X]  in 59 mL
    MERCURY (UNII: FXS1BY2PGL) (MERCURY - UNII:FXS1BY2PGL) MERCURY10 [hp_X]  in 59 mL
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS10 [hp_X]  in 59 mL
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR10 [hp_X]  in 59 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57955-1904-259 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/05/2014
    Labeler - King Bio Inc. (617901350)
    Registrant - King Bio Inc. (617901350)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio Inc.617901350manufacture(57955-1904)
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