Label: PARACLENZ- calcarea carbonica, chenopodium anthelminticum, cina, croton tiglium, filix mas, gambogia, granatum, lycopodium clavatum, mercurius corrosivus, natrum phosphoricum, santoninum, senna, spigelia anthelmia, stannum metallicum, tanacetum vulgare, teucrium marum, zingeber officinale 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 November 3, 2016

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  • ACTIVE INGREDIENT

    Drug Facts​__________________________________________________________________________________________________________

    HPUS active ingredients: Calcarea carbonica, Chenopodium anthelminticum, Cina, Croton tiglium, Filix mas, Gambogia, Granatum, Lycopodium clavatum, Mercurius corrosivus, Natrum phosphoricum, Santoninum, Senna, Spigelia anthelmia, Stannum metallicum, Tanacetum vulgare, Teucrium marum, Zingiber officinale. Equal volumes of each ingredient in 10X, 30X, 100X, 1M, 1LM, 2LM, 3LM potencies.

  • INDICATIONS & USAGE

    Uses for symptoms associated with parasites and worms: intestinal irritation, appetite swings, bad breath, constipation, itching nose or anus, angry or irritable moods.

  • 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 safety seal is intact. This product has not been independently tested.

  • PURPOSE

    Uses for symptoms associated with parasites and worms:

    • intestinal irritation
    • appetite swings
    • bad breath
    • constipation
    • itching nose or anus
    • angry or irritable moods
  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    PARACLENZ 
    calcarea carbonica, chenopodium anthelminticum, cina, croton tiglium, filix mas, gambogia, granatum, lycopodium clavatum, mercurius corrosivus, natrum phosphoricum, santoninum, senna, spigelia anthelmia, stannum metallicum, tanacetum vulgare, teucrium marum, zingeber officinale liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57955-0016
    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
    DYSPHANIA AMBROSIOIDES (UNII: 4H5RSU087I) (CHENOPODIUM AMBROSIOIDES - UNII:4H5RSU087I) DYSPHANIA AMBROSIOIDES10 [hp_X]  in 59 mL
    ARTEMISIA CINA PRE-FLOWERING TOP (UNII: 28M1820ACT) (ARTEMISIA CINA FLOWER - UNII:28M1820ACT) ARTEMISIA CINA PRE-FLOWERING TOP10 [hp_X]  in 59 mL
    CROTON TIGLIUM SEED (UNII: 0HK2GZK66E) (CROTON TIGLIUM SEED - UNII:0HK2GZK66E) CROTON TIGLIUM SEED10 [hp_X]  in 59 mL
    DRYOPTERIS FILIX-MAS ROOT (UNII: C0ZK0RRF5X) (DRYOPTERIS FILIX-MAS ROOT - UNII:C0ZK0RRF5X) DRYOPTERIS FILIX-MAS ROOT10 [hp_X]  in 59 mL
    GAMBOGE (UNII: 7556HJ7587) (GAMBOGE - UNII:7556HJ7587) GAMBOGE10 [hp_X]  in 59 mL
    PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D) (PUNICA GRANATUM ROOT BARK - UNII:CLV24I3T1D) PUNICA GRANATUM ROOT BARK10 [hp_X]  in 59 mL
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE10 [hp_X]  in 59 mL
    MERCURIC CHLORIDE (UNII: 53GH7MZT1R) (MERCURIC CATION - UNII:ED30FJ8Y42) MERCURIC CHLORIDE10 [hp_X]  in 59 mL
    SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE (UNII: 70WT22SF4B) (PHOSPHATE ION - UNII:NK08V8K8HR) SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE10 [hp_X]  in 59 mL
    SANTONIN (UNII: 1VL8J38ERO) (SANTONIN - UNII:1VL8J38ERO) SANTONIN10 [hp_X]  in 59 mL
    SENNA LEAF (UNII: AK7JF626KX) (SENNA LEAF - UNII:AK7JF626KX) SENNA LEAF10 [hp_X]  in 59 mL
    SPIGELIA ANTHELMIA (UNII: WYT05213GE) (SPIGELIA ANTHELMIA - UNII:WYT05213GE) SPIGELIA ANTHELMIA10 [hp_X]  in 59 mL
    TIN (UNII: 387GMG9FH5) (TIN - UNII:387GMG9FH5) TIN10 [hp_X]  in 59 mL
    TANACETUM VULGARE TOP (UNII: D52957JQ8M) (TANACETUM VULGARE TOP - UNII:D52957JQ8M) TANACETUM VULGARE TOP10 [hp_X]  in 59 mL
    TEUCRIUM MARUM (UNII: 10464S0TAA) (TEUCRIUM MARUM - UNII:10464S0TAA) TEUCRIUM MARUM10 [hp_X]  in 59 mL
    GINGER (UNII: C5529G5JPQ) (GINGER - UNII:C5529G5JPQ) GINGER10 [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:57955-0016-259 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product11/18/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic11/18/2011
    Labeler - King Bio Inc. (617901350)
    Registrant - King Bio Inc. (617901350)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio Inc.617901350manufacture(57955-0016)
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