Label: BABY TEETHING- agaicus muscarius, calcarea carbonica, calcarea fluorica, calcarea phosphorica, chamomilla, ferrum phosphoricum, hepar sulphuris calcareum, magnesia phosphorica, phytolacca decandra, podophyllum peltatum, rheum, 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 March 5, 2018

If you are a consumer or patient please visit this version.

  • HPUS Active Ingredients

    Agaicus muscarius, Calcarea carbonica, Calcarea fluorica, Calcarea phosphorica, Chamomilla, Ferrum phosphoricum, Hepar sulphuris calcareum, Magnesia phosphorica, Phytolacca decandra, Podophyllum peltatum, Rheum, Zincum metallicum

    Equal volumes of each in 30X, 60X, and 1LM potencies.

  • Purpose

    HPUS Ingredient:                                 Purpose:

    Agaicus muscarius...............................irritated gums

    Calcarea carbonica...............................sleeplessness, difficult, delayed teething

    Calcarea fluorica..................................toothache, vomiting in infants, supports dental development

    Calcarea phosphorica............................discomforts from teething

    Chamomilla..........................................desire to be held constantly

    Ferrum phosphoricum............................fever-like disturbaces

    Hepar sulphuris calcareum......................overly sensitive

    Magnesia phosphorica............................complaints of teething

    Phytolacca decandra...............................excess saliva, teething children, clenched teeth

    Podophyllum peltatum............................drooling, difficult dentition, fussiness, restlessness

    Rheum.................................................increased saliva, difficult teething, restlessness, irritability

    Zincum metallicum.................................difficult teething, irritability

  • Uses

    for temporary relief of: 

    • tething pain
    • irritated gums
    • delayed teething
    • fever-like disturbances
    • restlessness
    • heavy salivation and drooling
    • irritability
    • desire to be held constantly
  • Directions

    • Initially, depress pump until primed.
    • Spray one dose directly into mouth

    Under 3 months: Consult a licensed healthcare professional before using

    3 months to 2 years: 1 spray every 15 minutes. up to 4 doses, then hourly until relieved

    2 to 6 years: 2 sprays every 15 minutes, up to 4 doses, then hourly until relieved

  • Warnings

    • Stop use and ask a 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
  • Other Information

    • This product is intended to compliment, not replace, standard medical care.
    • Tamper resistant for your protection. Use only if safety seal is intact.
  • Inactive Ingredients

    Bio-Energetically Enhanced pure water, Carya ovata bark extract (hickory), citrus extract, Lonicer japonica (honeysuckle), polylysine (natural ferment), steviol glycosides (stevia)

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    BABY TEETHING 
    agaicus muscarius, calcarea carbonica, calcarea fluorica, calcarea phosphorica, chamomilla, ferrum phosphoricum, hepar sulphuris calcareum, magnesia phosphorica, phytolacca decandra, podophyllum peltatum, rheum, zincum metallicum liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57955-0467
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AMANITA MUSCARIA FRUITING BODY (UNII: DIF093I037) (AMANITA MUSCARIA FRUITING BODY - UNII:DIF093I037) AMANITA MUSCARIA FRUITING BODY30 [hp_X]  in 59 mL
    OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE30 [hp_X]  in 59 mL
    CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O) CALCIUM FLUORIDE30 [hp_X]  in 59 mL
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION30 [hp_X]  in 59 mL
    MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA30 [hp_X]  in 59 mL
    FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7) FERROSOFERRIC PHOSPHATE30 [hp_X]  in 59 mL
    CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE30 [hp_X]  in 59 mL
    MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE30 [hp_X]  in 59 mL
    PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT30 [hp_X]  in 59 mL
    PODOPHYLLUM (UNII: 2S713A4VP3) (PODOPHYLLUM - UNII:2S713A4VP3) PODOPHYLLUM30 [hp_X]  in 59 mL
    RHEUM OFFICINALE ROOT (UNII: A47JP5ZG9M) (RHEUM OFFICINALE ROOT - UNII:A47JP5ZG9M) RHEUM OFFICINALE ROOT30 [hp_X]  in 59 mL
    ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS) ZINC30 [hp_X]  in 59 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARYA OVATA BARK (UNII: X765CF609L)  
    CITRUS BIOFLAVONOIDS (UNII: BD70459I50)  
    LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)  
    POLYEPSILON-LYSINE (4000 MW) (UNII: WB0M8X4TWR)  
    REBAUDIOSIDE A (UNII: B3FUD0528F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57955-0467-21 in 1 CARTON03/05/2018
    159 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/05/2018
    Labeler - King Bio Inc (617901350)
    Registrant - King Bio Inc (617901350)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio Inc617901350manufacture(57955-0467)