Label: SKIN IRRITATION AND ITCH RESPONSE- agaricus muscarius, alumina, anagallis arvensis, antimonium tartaricum, apis mellifica, arsenicum album, arsenicum iodatum, bovista, causticum, dolichos pruriens, fagapyrum esculentum, graphites, kali muriaticum, lac defloratum, muriaticum acidum, oleander, petroleum, pix liquida, radium bromatum, rhus toxicodendron, selenium metallicum, sulphur, urtica urens liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 58066-7002-7 - Packager: Beaumont Bio Med
- 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 January 9, 2015
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- Official Label (Printer Friendly)
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ACTIVE INGREDIENT
HPUS active ingredients: Agaricus muscarius, Alumina, Anagallis arvensis, Antimonium tartaricum, Apis mellifica, Arsenicum album, Arsenicum iodatum, Bovista, Causticum, Dolichos pruriens, Fagopyrum esculentum, Graphites, Kali muriaticum, Lac defloratum, Muriaticum acidum, Oleander, Petroleum, Pix Liquida, Radium bromatum (12X, 30X, 100X), Rhus toxicodendron, Selenium metallicum, Sulphur, Urtica urens. Equal volumes of each ingredient in 10X, 30X, 100X potencies, unless otherwise noted.
- INACTIVE INGREDIENT
- INDICATIONS & USAGE
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DOSAGE & ADMINISTRATION
Directions:
- Hold close to mouth and spray 1 dose (3 complete pump sprays) directly in mouth 4-6 times daily until symptoms improve.
- Before initial dose, depress pump 4-5 times or until primed.
- Consult a physician for use in children under 12 years of age.
Use according to label indications and/or standard homeopathic indications.
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- PURPOSE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SKIN IRRITATION AND ITCH RESPONSE
agaricus muscarius, alumina, anagallis arvensis, antimonium tartaricum, apis mellifica, arsenicum album, arsenicum iodatum, bovista, causticum, dolichos pruriens, fagapyrum esculentum, graphites, kali muriaticum, lac defloratum, muriaticum acidum, oleander, petroleum, pix liquida, radium bromatum, rhus toxicodendron, selenium metallicum, sulphur, urtica urens liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58066-7002 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMANITA MUSCARIA FRUITING BODY (UNII: DIF093I037) (AMANITA MUSCARIA FRUITING BODY - UNII:DIF093I037) AMANITA MUSCARIA FRUITING BODY 10 [hp_X] in 59.2 mL ALUMINUM OXIDE (UNII: LMI26O6933) (ALUMINUM OXIDE - UNII:LMI26O6933) ALUMINUM OXIDE 10 [hp_X] in 59.2 mL ANAGALLIS ARVENSIS (UNII: 46883LR90E) (ANAGALLIS ARVENSIS - UNII:46883LR90E) ANAGALLIS ARVENSIS 10 [hp_X] in 59.2 mL ANTIMONY POTASSIUM TARTRATE (UNII: DL6OZ476V3) (ANTIMONY CATION (3+) - UNII:069647RPT5) ANTIMONY POTASSIUM TARTRATE 10 [hp_X] in 59.2 mL APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA 10 [hp_X] in 59.2 mL ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE 10 [hp_X] in 59.2 mL ARSENIC TRIIODIDE (UNII: 3029988O2T) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIIODIDE 10 [hp_X] in 59.2 mL LYCOPERDON UTRIFORME FRUITING BODY (UNII: K2A74U428F) (LYCOPERDON UTRIFORME FRUITING BODY - UNII:K2A74U428F) LYCOPERDON UTRIFORME FRUITING BODY 10 [hp_X] in 59.2 mL CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU) CAUSTICUM 10 [hp_X] in 59.2 mL MUCUNA PRURIENS FRUIT TRICHOME (UNII: 3E271BSI0C) (MUCUNA PRURIENS FRUIT TRICHOME - UNII:3E271BSI0C) MUCUNA PRURIENS FRUIT TRICHOME 10 [hp_X] in 59.2 mL FAGOPYRUM ESCULENTUM (UNII: B10M69172N) (FAGOPYRUM ESCULENTUM - UNII:B10M69172N) FAGOPYRUM ESCULENTUM 10 [hp_X] in 59.2 mL GRAPHITE (UNII: 4QQN74LH4O) (GRAPHITE - UNII:4QQN74LH4O) GRAPHITE 10 [hp_X] in 59.2 mL POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM CHLORIDE 10 [hp_X] in 59.2 mL SKIM MILK (UNII: 6A001Y4M5A) (SKIM MILK - UNII:6A001Y4M5A) SKIM MILK 10 [hp_X] in 59.2 mL HYDROCHLORIC ACID (UNII: QTT17582CB) (HYDROCHLORIC ACID - UNII:QTT17582CB) HYDROCHLORIC ACID 10 [hp_X] in 59.2 mL NERIUM OLEANDER LEAF (UNII: 7KV510R6H6) (NERIUM OLEANDER LEAF - UNII:7KV510R6H6) NERIUM OLEANDER LEAF 10 [hp_X] in 59.2 mL KEROSENE (UNII: 1C89KKC04E) (KEROSENE - UNII:1C89KKC04E) KEROSENE 10 [hp_X] in 59.2 mL PINE TAR (UNII: YFH4WC535J) (PINE TAR - UNII:YFH4WC535J) PINE TAR 10 [hp_X] in 59.2 mL RADIUM BROMIDE (UNII: R74O7T8569) (RADIUM CATION - UNII:05456MVL7T) RADIUM BROMIDE 12 [hp_X] in 59.2 mL TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF 10 [hp_X] in 59.2 mL SELENIUM (UNII: H6241UJ22B) (SELENIUM - UNII:H6241UJ22B) SELENIUM 10 [hp_X] in 59.2 mL SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 10 [hp_X] in 59.2 mL URTICA URENS (UNII: IHN2NQ5OF9) (URTICA URENS - UNII:IHN2NQ5OF9) URTICA URENS 10 [hp_X] in 59.2 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58066-7002-7 59.2 mL in 1 BOTTLE, SPRAY Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 01/16/2013 Labeler - Beaumont Bio Med (070624288) Registrant - Beaumont Bio Med (070624288) Establishment Name Address ID/FEI Business Operations King Bio Inc. 617901350 manufacture(58066-7002)
