CHILDRENS EAR RELIEF- aconitum napellus, allium cepa, apis mellifica, belladonna, calcarea carbonica, capsicum annuum, causticum, chamomilla, dulcamara, ferrum phosphoricum, hepar sulphuris calcareum, kali muriaticum, mercurius dulcis, mercurius solubilis, plantago major, silicea liquid

Childrens Ear Relief by

Drug Labeling and Warnings

Childrens Ear Relief by is a Homeopathic medication manufactured, distributed, or labeled by King Bio Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Drug Facts

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HPUS active ingredients: Aconitum napellus, Allium cepa, Apis mellifica, Belladonna, Calcarea carbonica, Capsicum annuum, Causticum, Chamomilla, Dulcamara, Ferrum phosphoricum, Hepar sulphuris calcareum, Kali muriaticum, Mercurius dulcis, Mercurius solubilis, Plantago major, Silicea. Equal volumes of each ingredient in 10X, 30X, 100X, 1M, LM1, LM2, LM3 potencies.

INDICATIONS & USAGE

Uses  NOTE: Do not use in ear. Oral spray only. For temporary relief of symptoms: clogged sensation, noises in ear, accumulation of ear wax.

INACTIVE INGREDIENT

Inactive ingredients: Bio-Energetically Enhanced pure water, citric acid, 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.-2yr.- 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 NOTE: Do not use in ear. Oral spray only. For temporary relief of symptoms:

• clogged sensation
• noises in ear
• accumulation of ear wax

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CHILDRENS EAR RELIEF 
aconitum napellus, allium cepa, apis mellifica, belladonna, calcarea carbonica, capsicum annuum, causticum, chamomilla, dulcamara, ferrum phosphoricum, hepar sulphuris calcareum, kali muriaticum, mercurius dulcis, mercurius solubilis, plantago major, silicea liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57955-0758
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD)	ACONITUM NAPELLUS	10 [hp_X]  in 59 mL
ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H)	ONION	10 [hp_X]  in 59 mL
APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z)	APIS MELLIFERA	10 [hp_X]  in 59 mL
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	10 [hp_X]  in 59 mL
OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I)	OYSTER SHELL CALCIUM CARBONATE, CRUDE	10 [hp_X]  in 59 mL
CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG)	CAPSICUM	10 [hp_X]  in 59 mL
CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU)	CAUSTICUM	10 [hp_X]  in 59 mL
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ)	MATRICARIA RECUTITA	10 [hp_X]  in 59 mL
SOLANUM DULCAMARA TOP (UNII: KPS1B1162N) (SOLANUM DULCAMARA TOP - UNII:KPS1B1162N)	SOLANUM DULCAMARA TOP	10 [hp_X]  in 59 mL
FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7)	FERROSOFERRIC PHOSPHATE	10 [hp_X]  in 59 mL
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q)	CALCIUM SULFIDE	10 [hp_X]  in 59 mL
POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152)	POTASSIUM CHLORIDE	10 [hp_X]  in 59 mL
CALOMEL (UNII: J2D46N657D) (CALOMEL - UNII:J2D46N657D)	CALOMEL	10 [hp_X]  in 59 mL
MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2)	MERCURIUS SOLUBILIS	10 [hp_X]  in 59 mL
PLANTAGO MAJOR (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U)	PLANTAGO MAJOR	10 [hp_X]  in 59 mL
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (COLLOIDAL SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	10 [hp_X]  in 59 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57955-0758-2	59 mL in 1 BOTTLE, SPRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		03/31/2014

Labeler - King Bio Inc. (617901350)

Registrant - King Bio Inc. (617901350)

Establishment
Name	Address	ID/FEI	Business Operations
King Bio Inc.		617901350	manufacture(57955-0758)