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 
King Bio Inc

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.

----------

Baby Teething

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: 

Directions

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

Other Information

Inactive Ingredients

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

image description

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)

Revised: 3/2018
Document Id: 06d263cc-c43b-49a0-8cc5-2dd4840f2c6f
Set id: fbd2b2b3-a1e8-4f62-848e-e05b89b8ee47
Version: 1
Effective Time: 20180305
 
King Bio Inc