Label: BETTER BREATH- arnica montana, arsenicum album, aurum metallicum, baptisia tinctoria, calcarea carbonica, calcarea fluorica, carbo vegetabilis, carbolicum acidum, gambogia, hekla lava, iodium, kali phosphoricum, kreosotum, mercurius corrosivus, mercurius vivus, nitricum acidum, petroleum, quercus robur, staphysagria, sulphur liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 57955-1903-2 - Packager: King Bio Inc.
- 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 May 5, 2014
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ACTIVE INGREDIENT
Drug Facts__________________________________________________________________________________________________________
HPUS active ingredients: Arnica montana, Arsenicum album, Aurum metallicum, Baptisia tinctoria, Calcarea carbonica, Calcarea fluorica, Carbo vegetabilis, Carbolicum acidum, Gambogia, Hekla lava, Iodium, Kali phosphoricum, Kreosotum, Mercurius corrosivus, Mercurius vivus, Nitricum acidum, Petroleum, Quercus robur, Staphysagria, Sulphur. Equal volumes of each ingredient in 10X, 30X, LM1 potencies.
- INDICATIONS & USAGE
- INACTIVE INGREDIENT
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- PURPOSE
- PRINCIPAL DISPLAY PANEL
- SPL UNCLASSIFIED SECTION
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INGREDIENTS AND APPEARANCE
BETTER BREATH
arnica montana, arsenicum album, aurum metallicum, baptisia tinctoria, calcarea carbonica, calcarea fluorica, carbo vegetabilis, carbolicum acidum, gambogia, hekla lava, iodium, kali phosphoricum, kreosotum, mercurius corrosivus, mercurius vivus, nitricum acidum, petroleum, quercus robur, staphysagria, sulphur liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57955-1903 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA 10 [hp_X] in 59 mL ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE 10 [hp_X] in 59 mL GOLD (UNII: 79Y1949PYO) (GOLD - UNII:79Y1949PYO) GOLD 10 [hp_X] in 59 mL BAPTISIA TINCTORIA ROOT (UNII: 5EF0HWI5WU) (BAPTISIA TINCTORIA ROOT - UNII:5EF0HWI5WU) BAPTISIA TINCTORIA ROOT 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 CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O) CALCIUM FLUORIDE 10 [hp_X] in 59 mL ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10) ACTIVATED CHARCOAL 10 [hp_X] in 59 mL PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) PHENOL 10 [hp_X] in 59 mL GAMBOGE (UNII: 7556HJ7587) (GAMBOGE - UNII:7556HJ7587) GAMBOGE 10 [hp_X] in 59 mL HEKLA LAVA (UNII: C21158IIRK) (HEKLA LAVA - UNII:C21158IIRK) HEKLA LAVA 10 [hp_X] in 59 mL IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4) IODINE 10 [hp_X] in 59 mL POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR) POTASSIUM PHOSPHATE, DIBASIC 10 [hp_X] in 59 mL WOOD CREOSOTE (UNII: 3JYG22FD73) (WOOD CREOSOTE - UNII:3JYG22FD73) WOOD CREOSOTE 10 [hp_X] in 59 mL MERCURIC CHLORIDE (UNII: 53GH7MZT1R) (MERCURIC CATION - UNII:ED30FJ8Y42) MERCURIC CHLORIDE 10 [hp_X] in 59 mL MERCURY (UNII: FXS1BY2PGL) (MERCURY - UNII:FXS1BY2PGL) MERCURY 10 [hp_X] in 59 mL NITRIC ACID (UNII: 411VRN1TV4) (NITRIC ACID - UNII:411VRN1TV4) NITRIC ACID 10 [hp_X] in 59 mL KEROSENE (UNII: 1C89KKC04E) (KEROSENE - UNII:1C89KKC04E) KEROSENE 10 [hp_X] in 59 mL QUERCUS ROBUR TWIG BARK (UNII: 2JFK226947) (QUERCUS ROBUR TWIG BARK - UNII:2JFK226947) QUERCUS ROBUR TWIG BARK 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 SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 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:57955-1903-2 59 mL in 1 BOTTLE, SPRAY Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 05/05/2014 Labeler - King Bio Inc. (617901350) Registrant - King Bio Inc. (617901350) Establishment Name Address ID/FEI Business Operations King Bio Inc. 617901350 manufacture(57955-1903)