Label: TEETH AND GUMS FORMULA- calcarea carbonica, calcarea fluorica, calcarea phosphorica, chamomilla, coccinella septempunctata, coffea cruda, hekla lava, hypericum perforatum, kreosotum, ledum palustre, magnesia phosphorica, mercurius vivus liquid

  • Category: HUMAN OTC DRUG LABEL

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 June 24, 2016

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  • ACTIVE INGREDIENT

    Drug Facts​__________________________________________________________________________________________________________

    HPUS active ingredients: Calcarea carbonica, Calcarea fluorica, Calcarea phosphorica, Chamomilla, Coccinella septempunctata, Coffea cruda, Hekla lava, Hypericum perforatum, Kreosotum, Ledum palustre, Magnesia phosphorica, Mercurius vivus​. Equal volumes of each ingredient in 10X, 30X, LM1 potencies.

  • INDICATIONS & USAGE

    Uses for temporary relief of symptoms associated with cavities or dental procedures: sensitivities, mouth or gum pain, bleeding gums, loose 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 for temporary relief of symptoms associated with cavities or dental procedures:

    • sensitivities
    • mouth or gum pain
    • bleeding gums
    • loose teeth
  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    TEETH AND GUMS FORMULA 
    calcarea carbonica, calcarea fluorica, calcarea phosphorica, chamomilla, coccinella septempunctata, coffea cruda, hekla lava, hypericum perforatum, kreosotum, ledum palustre, magnesia phosphorica, mercurius vivus liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57955-5073
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE10 [hp_X]  in 59 mL
    CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O) CALCIUM FLUORIDE10 [hp_X]  in 59 mL
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION10 [hp_X]  in 59 mL
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA10 [hp_X]  in 59 mL
    COCCINELLA SEPTEMPUNCTATA (UNII: 9894B4Y2EN) (COCCINELLA SEPTEMPUNCTATA - UNII:9894B4Y2EN) COCCINELLA SEPTEMPUNCTATA10 [hp_X]  in 59 mL
    ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN10 [hp_X]  in 59 mL
    HEKLA LAVA (UNII: C21158IIRK) (HEKLA LAVA - UNII:C21158IIRK) HEKLA LAVA10 [hp_X]  in 59 mL
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM10 [hp_X]  in 59 mL
    WOOD CREOSOTE (UNII: 3JYG22FD73) (WOOD CREOSOTE - UNII:3JYG22FD73) WOOD CREOSOTE10 [hp_X]  in 59 mL
    LEDUM PALUSTRE TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P) LEDUM PALUSTRE TWIG10 [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
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57955-5073-259 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/24/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic06/24/2016
    Labeler - King Bio Inc. (617901350)
    Registrant - King Bio Inc. (617901350)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio Inc.617901350manufacture(57955-5073)
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