NDC | 57955-0467-2 |
Set ID | fbd2b2b3-a1e8-4f62-848e-e05b89b8ee47 |
Category | HUMAN OTC DRUG LABEL |
Packager | King Bio Inc |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
- HPUS Active Ingredients
-
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
-
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
- KEEP OUT OF REACH OF CHILDREN
- Other Information
- Inactive Ingredients
- PRINCIPAL DISPLAY PANEL
-
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 liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57955-0467 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMANITA MUSCARIA FRUITING BODY (UNII: DIF093I037) (AMANITA MUSCARIA FRUITING BODY - UNII:DIF093I037) AMANITA MUSCARIA FRUITING BODY 30 [hp_X] in 59 mL OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE 30 [hp_X] in 59 mL CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O) CALCIUM FLUORIDE 30 [hp_X] in 59 mL TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION 30 [hp_X] in 59 mL MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA 30 [hp_X] in 59 mL FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7) FERROSOFERRIC PHOSPHATE 30 [hp_X] in 59 mL CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE 30 [hp_X] in 59 mL MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 30 [hp_X] in 59 mL PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT 30 [hp_X] in 59 mL PODOPHYLLUM (UNII: 2S713A4VP3) (PODOPHYLLUM - UNII:2S713A4VP3) PODOPHYLLUM 30 [hp_X] in 59 mL RHEUM OFFICINALE ROOT (UNII: A47JP5ZG9M) (RHEUM OFFICINALE ROOT - UNII:A47JP5ZG9M) RHEUM OFFICINALE ROOT 30 [hp_X] in 59 mL ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS) ZINC 30 [hp_X] in 59 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:57955-0467-2 1 in 1 CARTON 03/05/2018 1 59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 03/05/2018 Labeler - King Bio Inc (617901350) Registrant - King Bio Inc (617901350) Establishment Name Address ID/FEI Business Operations King Bio Inc 617901350 manufacture(57955-0467)