SMOKE FREEE- arsenicum album, caladium seguinum, carbolicum acidum, daphne indica, eugenia jambosa, kali phosphoricum, lobelia inflata, nicotinum, nux vomica, plantago major, saccharum officinale, staphysagria, tabacum, thuja occidentalis liquid

Smoke Freee by

Drug Labeling and Warnings

Smoke Freee by is a Homeopathic medication manufactured, distributed, or labeled by New Sun Inc., King Bio Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOSAGE & ADMINISTRATION

Directions: Before initial dose depress pump 4-5 times or until primed and spray 1 dose directly in mouth 4 to 6 times daily until symptoms improve.

Adult Dose: 3 Pump Sprays

Child's Dose (2-12): 2 Pump Sprays

Infants - 2 yrs: 1 Pump Spray

WARNINGS

Warnings: If symptoms persist or worsen, seek advice of a physician. If pregnant or breast-feeding, take only on advice of physician.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

OTHER SAFETY INFORMATION

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

PURPOSE

Indications: Temporarily relieves cravings for: tobacco smoke chew

Temporary relieves: nervousness, anxiety & irritability when quitting cough/shortness of breath difficulty breathing sensation of weight on chest from smoking

ACTIVE INGREDIENT

Active Ingredients: Arsenicum album, Caladium seguinum, Carbolicum acidum, Daphne indica, Eugenia jambosa, Kali phosphoricum, Lobelia inflata, Nicotinum, Nux vomica, Plantago major, Saccharum officinale, Staphysagria, Tabacum, Thuja occidentalis. ​Equal volumes of each ingredient in 10X, 30X, and 100X potencies.

INACTIVE INGREDIENT

Inactive Ingredient: Citric acid, potassium sorbate, purified water.

INDICATIONS & USAGE

Indications: Temporarily relieves cravings for:

• tobacco smoke 
• chew

Temporary relieves:

• nervousness, anxiety & irritability when quitting
• cough/shortness of breath
• difficulty breathing
• sensation of weight on chest from smoking​

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SMOKE FREEE 
arsenicum album, caladium seguinum, carbolicum acidum, daphne indica, eugenia jambosa, kali phosphoricum, lobelia inflata, nicotinum, nux vomica, plantago major, saccharum officinale, staphysagria, tabacum, thuja occidentalis liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66579-0075
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV)	ARSENIC TRIOXIDE	10 [hp_X]  in 59 mL
DIEFFENBACHIA SEGUINE (UNII: 01800C6E6B) (DIEFFENBACHIA SEGUINE - UNII:01800C6E6B)	DIEFFENBACHIA SEGUINE	10 [hp_X]  in 59 mL
PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV)	PHENOL	10 [hp_X]  in 59 mL
DAPHNE ODORA BARK (UNII: JSJ34YQJ5D) (DAPHNE ODORA BARK - UNII:JSJ34YQJ5D)	DAPHNE ODORA BARK	10 [hp_X]  in 59 mL
SYZYGIUM JAMBOS SEED (UNII: 97P0H45869) (SYZYGIUM JAMBOS SEED - UNII:97P0H45869)	SYZYGIUM JAMBOS SEED	10 [hp_X]  in 59 mL
POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR)	POTASSIUM PHOSPHATE, DIBASIC	10 [hp_X]  in 59 mL
LOBELIA INFLATA (UNII: 9PP1T3TC5U) (LOBELIA INFLATA - UNII:9PP1T3TC5U)	LOBELIA INFLATA	10 [hp_X]  in 59 mL
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R)	NICOTINE	10 [hp_X]  in 59 mL
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	10 [hp_X]  in 59 mL
PLANTAGO MAJOR (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U)	PLANTAGO MAJOR	10 [hp_X]  in 59 mL
SUCROSE (UNII: C151H8M554) (SUCROSE - UNII:C151H8M554)	SUCROSE	10 [hp_X]  in 59 mL
DELPHINIUM STAPHISAGRIA SEED (UNII: 00543AP1JV) (DELPHINIUM STAPHISAGRIA SEED - UNII:00543AP1JV)	DELPHINIUM STAPHISAGRIA SEED	10 [hp_X]  in 59 mL
TOBACCO LEAF (UNII: 6YR2608RSU) (TOBACCO LEAF - UNII:6YR2608RSU)	TOBACCO LEAF	10 [hp_X]  in 59 mL
THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397)	THUJA OCCIDENTALIS LEAFY TWIG	10 [hp_X]  in 59 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66579-0075-2	59 mL in 1 BOTTLE, SPRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		02/02/2012

Labeler - New Sun Inc. (957251176)

Registrant - New Sun Inc. (957251176)

Establishment
Name	Address	ID/FEI	Business Operations
King Bio Inc.		617901350	manufacture(66579-0075)