Label: SMOKE-X- arsenicum album,plantago major,thuja occidentalis,tabacum,staphysagria,saccharum officinale,daphne indica,nux vomica,nicotinum,lobelia inflata,kali phosphoricum,eugenia jambosa,carbolicum acidum,caladium seguinum, liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 61657-0915-1 - Packager: White Manufacturing Inc. DBA Micro-West
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
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.
Drug Label Information
Updated December 6, 2012
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ACTIVE INGREDIENT
EACH MULTIPLE CONCENTRATES OF 10X, 30X, 100X
ARSENICUM ALBUM [HPUS]
CALADIUM SEGUINUM [HPUS)
CARBOLICUM ACIDUM [HPUS]
DAPHNE INDICA [HPUS]
EUGENIA JAMBOSA [HPUS]
KALI PHOSPHORICUM [HPUS]
LOBELIA INFLATIA
NICOTINUM [HPUS]
NUX VOMICA [HPUS]
PLANTAGO MAJOR [HPUS]
SACCHARUM OFFICINALE [HPUS]
STAPHYSAGRIA [HPUS]
TABACUM [HPUS]
THUJA OCCIDENTALIS
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
- DIRECTIONS
- INACTIVE INGREDIENT
- MANUFACTURE
- LABEL
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INGREDIENTS AND APPEARANCE
SMOKE-X
arsenicum album,plantago major,thuja occidentalis,tabacum,staphysagria,saccharum officinale,daphne indica,nux vomica,nicotinum,lobelia inflata,kali phosphoricum,eugenia jambosa,carbolicum acidum,caladium seguinum, liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61657-0915 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 30 mL DIEFFENBACHIA SEGUINE (UNII: 01800C6E6B) (DIEFFENBACHIA SEGUINE - UNII:01800C6E6B) DIEFFENBACHIA SEGUINE 10 [hp_X] in 30 mL PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) PHENOL 10 [hp_X] in 30 mL DAPHNE ODORA BARK (UNII: JSJ34YQJ5D) (DAPHNE ODORA BARK - UNII:JSJ34YQJ5D) DAPHNE ODORA BARK 10 [hp_X] in 30 mL SYZYGIUM JAMBOS SEED (UNII: 97P0H45869) (SYZYGIUM JAMBOS SEED - UNII:97P0H45869) SYZYGIUM JAMBOS SEED 10 [hp_X] in 30 mL POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR) POTASSIUM PHOSPHATE, DIBASIC 10 [hp_X] in 30 mL LOBELIA INFLATA (UNII: 9PP1T3TC5U) (LOBELIA INFLATA - UNII:9PP1T3TC5U) LOBELIA INFLATA 10 [hp_X] in 30 mL NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE 10 [hp_X] in 30 mL STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED 10 [hp_X] in 30 mL PLANTAGO MAJOR (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U) PLANTAGO MAJOR 10 [hp_X] in 30 mL SUCROSE (UNII: C151H8M554) (SUCROSE - UNII:C151H8M554) SUCROSE 10 [hp_X] in 30 mL DELPHINIUM STAPHISAGRIA SEED (UNII: 00543AP1JV) (DELPHINIUM STAPHISAGRIA SEED - UNII:00543AP1JV) DELPHINIUM STAPHISAGRIA SEED 10 [hp_X] in 30 mL TOBACCO LEAF (UNII: 6YR2608RSU) (TOBACCO LEAF - UNII:6YR2608RSU) TOBACCO LEAF 10 [hp_X] in 30 mL THUJA OCCIDENTALIS LEAF (UNII: 0T0DQN8786) (THUJA OCCIDENTALIS LEAF - UNII:0T0DQN8786) THUJA OCCIDENTALIS LEAF 10 [hp_X] in 30 mL Inactive Ingredients Ingredient Name Strength POTASSIUM SORBATE (UNII: 1VPU26JZZ4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61657-0915-1 30 mL in 1 BOTTLE, PUMP Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 07/20/2006 Labeler - White Manufacturing Inc. DBA Micro-West (082307831) Establishment Name Address ID/FEI Business Operations White Manufacturing Inc. DBA Micro-West 082307831 label(61657-0915) , pack(61657-0915) Establishment Name Address ID/FEI Business Operations King Bio Homeopathic 617901350 manufacture(61657-0915)