Label: CALCIUM METABOLIZER- calcarea acetica, calcarea carbonica, calcarea caustica, calcarea fluorica, calcarea iodata, calcarea lactica, calcarea muriatica, calcarea oxalica, calcarea phosphorica, calcarea silicata, calcarea sulphurica, hekla lava, silicea 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 December 2, 2016

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  • ACTIVE INGREDIENT

    Drug Facts​__________________________________________________________________________________________________________

    HPUS active ingredients: Calcarea acetica, Calcarea carbonica, Calcarea caustica, Calcarea fluorica, Calcarea iodata, Calcarea lactica, Calcarea muriatica, Calcarea oxalica, Calcarea phosphorica, Calcarea silicata, Calcarea sulphurica, Hekla lava, Silicea. Equal volumes of each ingredient in 10X, 30X, 100X, 1M, 1LM, 2LM, 3LM potencies.

  • INDICATIONS & USAGE

    Uses ​for temporary relief of spasms, twitches, nervousness, brittle nails, aching joints, tooth decay, disturbed sleep.

  • 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, take only on advice of a healthcare professional.
  • 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.
    • Adults 12 and up: 3 sprays 3 times per day.
    • Children 2-12: 2 sprays 3 times per day.
    • Children 2 mo-2 yr: 1 spray 3 times per day.
  • OTHER SAFETY INFORMATION

    Tamper resistant for your protection. Use only if seal is intact. This product has not been independently tested.

  • PURPOSE

    Uses for temporary relief of:

    • spasms
    • twitches
    • nervousness
    • brittle nails,
    • aching joints
    • tooth decay
    • disturbed sleep
  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    CALCIUM METABOLIZER 
    calcarea acetica, calcarea carbonica, calcarea caustica, calcarea fluorica, calcarea iodata, calcarea lactica, calcarea muriatica, calcarea oxalica, calcarea phosphorica, calcarea silicata, calcarea sulphurica, hekla lava, silicea liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57955-0131
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM ACETATE (UNII: Y882YXF34X) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM ACETATE10 [hp_X]  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
    CALCIUM HYDROXIDE (UNII: PF5DZW74VN) (CALCIUM HYDROXIDE - UNII:PF5DZW74VN) CALCIUM HYDROXIDE10 [hp_X]  in 59 mL
    CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O) CALCIUM FLUORIDE10 [hp_X]  in 59 mL
    CALCIUM IODIDE (UNII: 8EKI9QEE2H) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM IODIDE10 [hp_X]  in 59 mL
    CALCIUM LACTATE PENTAHYDRATE (UNII: 4FM1N296CM) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM LACTATE PENTAHYDRATE10 [hp_X]  in 59 mL
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CHLORIDE10 [hp_X]  in 59 mL
    CALCIUM OXALATE MONOHYDRATE (UNII: 4PP86KK527) (CALCIUM CATION - UNII:2M83C4R6ZB, OXALIC ACID - UNII:9E7R5L6H31) CALCIUM OXALATE MONOHYDRATE10 [hp_X]  in 59 mL
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION10 [hp_X]  in 59 mL
    CALCIUM SILICATE (UNII: S4255P4G5M) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM SILICATE10 [hp_X]  in 59 mL
    CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM SULFATE ANHYDROUS10 [hp_X]  in 59 mL
    HEKLA LAVA (UNII: C21158IIRK) (HEKLA LAVA - UNII:C21158IIRK) HEKLA LAVA10 [hp_X]  in 59 mL
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE10 [hp_X]  in 59 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57955-0131-259 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product02/20/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic02/20/2015
    Labeler - King Bio Inc. (617901350)
    Registrant - King Bio Inc. (617901350)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio Inc.617901350manufacture(57955-0131)
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