Label: TEETHING- agaricus muscarius, belladonna, calcarea carbonica, calcarea phosphorica, chamomilla, ferrum phosphoricum, kreosotum and zincum metallicum 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 June 14, 2012

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  • Active Ingredients

    Official HPUS: Agaricus muscarius, Belladonna, Calcarea carbonica, Calcarea phosphorica, Chamomilla, Ferrum phosphoricum, Kreosotum and Zincum metallicum.

    Reference image teething.jpg

  • Inactive Ingredient

    Equal volumes of each ingredient in a Bio-Energetically Enhanced pure water base: 10X, 30X, and LM1 potencies.

    Reference image teething.jpg

  • Purpose

    Uses for temporary relief of teething pain

    • swelling gums
    • delayed teething
    • low grade fever
    • restlessness
    • heavy salivation
    • irritability
    • desire to be held constantly
    Reference image teething.jpg
  • Dosage and Administration

    Directions: Initially, depress pump until primed. Hold close to mouth and spray directly into mouth. Use 3 times daily. Use additionally as needed.

    Adult Dose 3 pump sprays

    Children 2-12 years 2 pump sprays

    Reference image teething.jpg

  • Warnings

    If symptoms persist or worsen, consult a physician. If pregnant or nursing, take only on advice of a healthcare professional. Keep out of reach of children.

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

    Reference image teething.jpg

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    Reference image teething.jpg

  • Indications and Usage

    Uses for temporary relief of teething pain: swelling gums, delayed teething, low grade fever, restlessness, heavy salivation, irritability, desire to be held constantly.

    Reference image teething.jpg

  • PRINCIPAL DISPLAY PANEL

    Image of label

    King Bio Inc.

    3 Westside Drive

    Asheville, NC 28806

    Questions? Call 800.543.3245

    www.kingbio.com

    Safe and Natural

    Reference image teething.jpg

  • INGREDIENTS AND APPEARANCE
    TEETHING 
    agaricus muscarius, belladonna, calcarea carbonica, calcarea phosphorica, chamomilla, ferrum phosphoricum, kreosotum and zincum metallicum liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57955-5018
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY (UNII: DIF093I037) (AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY - UNII:DIF093I037) AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY10 [hp_X]  in 59 mL
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA10 [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
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB) TRIBASIC CALCIUM PHOSPHATE10 [hp_X]  in 59 mL
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA10 [hp_X]  in 59 mL
    FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7) (FERRIC CATION - UNII:91O4LML611) FERROSOFERRIC PHOSPHATE10 [hp_X]  in 59 mL
    WOOD CREOSOTE (UNII: 3JYG22FD73) (WOOD CREOSOTE - UNII:3JYG22FD73) WOOD CREOSOTE10 [hp_X]  in 59 mL
    ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS) ZINC10 [hp_X]  in 59 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57955-5018-259 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/03/2012
    Labeler - King Bio Inc. (617901350)
    Registrant - King Bio Inc. (617901350)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio Inc.617901350manufacture
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