NEWBORN TONIC- aconitum napellus, bovista, bryonia, chamomilla, cinchona officinalis, lupulinum, mercurius vivus, myrica cerifera, natrum sulphuricum, phosphorus, sepia liquid

Newborn Tonic by

Drug Labeling and Warnings

Newborn Tonic 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__________________________________________________________________________________________________________

HPUS active ingredients: Aconitum napellus, Bovista, Bryonia, Chamomilla, Cinchona officinalis, Lupulinum, Mercurius vivus, Myrica cerifera, Natrum sulphuricum, Phosphorus, Sepia. Equal volumes of each ingredient in 10X, 30X, LM1 potencies.

INDICATIONS & USAGE

Uses for temporary relief of symptoms: skin rashes, skin discoloration, minor skin problems.

INACTIVE INGREDIENT

Inactive Ingredients:

Bio-Energetically Enhanced™ pure water, citric acid and potassium sorbate.

WARNINGS

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

DOSAGE & ADMINISTRATION

• Initially, depress pump until primed.
• ​​Spray one dose directly into mouth.
• Ages 12 and up - 3 sprays 3 times per day.
• Ages 2-12 - 2 sprays 3 times per day.
• Ages 2 months-2 years - 1 spray 3 times per day.

OTHER SAFETY INFORMATION

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

PURPOSE

Uses for temporary relief of symptoms:

• skin rashes
• skin discoloration
• minor skin problems

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NEWBORN TONIC 
aconitum napellus, bovista, bryonia, chamomilla, cinchona officinalis, lupulinum, mercurius vivus, myrica cerifera, natrum sulphuricum, phosphorus, sepia liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57955-5114
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
LYCOPERDON UTRIFORME FRUITING BODY (UNII: K2A74U428F) (LYCOPERDON UTRIFORME FRUITING BODY - UNII:K2A74U428F)	LYCOPERDON UTRIFORME FRUITING BODY	10 [hp_X]  in 59 mL
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	10 [hp_X]  in 59 mL
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ)	MATRICARIA RECUTITA	10 [hp_X]  in 59 mL
CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB)	CINCHONA OFFICINALIS BARK	10 [hp_X]  in 59 mL
HOPS (UNII: 01G73H6H83) (HOPS - UNII:01G73H6H83)	HOPS	10 [hp_X]  in 59 mL
MERCURY (UNII: FXS1BY2PGL) (MERCURY - UNII:FXS1BY2PGL)	MERCURY	10 [hp_X]  in 59 mL
MORELLA CERIFERA ROOT BARK (UNII: S46HJ3710D) (MORELLA CERIFERA ROOT BARK - UNII:S46HJ3710D)	MORELLA CERIFERA ROOT BARK	10 [hp_X]  in 59 mL
SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM SULFATE ANHYDROUS - UNII:36KCS0R750)	SODIUM SULFATE	10 [hp_X]  in 59 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	10 [hp_X]  in 59 mL
SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2)	SEPIA OFFICINALIS JUICE	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: 57955-5114-2	59 mL in 1 BOTTLE, SPRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		03/20/2014

Labeler - King Bio Inc. (617901350)

Registrant - King Bio Inc. (617901350)

Establishment
Name	Address	ID/FEI	Business Operations
King Bio Inc.		617901350	manufacture(57955-5114)