Label: EDEMA- elaps corallinus , apis mel., arsenicum alb. , cantharis, cinchona , colchicum , convallaria , crotalus horridus , digitalis , juniperus com , lachesis , merc. viv. , naja , nat. carb. , nat. sulphuricum , rhus toxicodendron , sambucus nig. , strophanthus hispidus , thuja occ. , vipera berus , echinacea , lappa , solidago , taraxacum , urtica ur. pellet
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Contains inactivated NDC Code(s)
NDC Code(s): 55714-4543-1, 55714-4543-2 - Packager: Newton Laboratories, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
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 June 1, 2011
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- INDICATIONS & USAGE SECTION
- DOSAGE & ADMINISTRATION SECTION
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ACTIVE INGREDIENT SECTION
Elaps corallinus 35x, Apis mel.15x, Arsenicum alb. 15x, Cantharis 15x, Cinchona 15x, Colchicum 15x, Convallaria 15x, Crotalus horridus 15x, Digitalis 15x, Juniperus com 15x, Lachesis 15x, Merc. viv. 15x, Naja 15x, Nat. carb. 15x, Nat. sulphuricum 15x, Rhus toxicodendron 15x, Sambucus nig. 15x, Strophanthus hispidus 15x, Thuja occ. 15x, Vipera berus 15x, Echinacea 8x, Lappa 8x, Solidago 8x, Taraxacum 8x, Urtica ur. 8x, Echinacea 3x, Lappa 3x, Solidago 3x, Taraxacum 3x, Urtica ur. 3x.
- PURPOSE SECTION
- INACTIVE INGREDIENT SECTION
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QUESTIONS? SECTION
www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
Questions? 1.800.448.7256 - WARNINGS SECTION
- PREGNANCY OR BREAST FEEDING SECTION
- KEEP OUT OF REACH OF CHILDREN SECTION
- PACKAGE LABEL
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INGREDIENTS AND APPEARANCE
EDEMA
elaps corallinus , apis mel., arsenicum alb. , cantharis, cinchona , colchicum , convallaria , crotalus horridus , digitalis , juniperus com , lachesis , merc. viv. , naja , nat. carb. , nat. sulphuricum , rhus toxicodendron , sambucus nig. , strophanthus hispidus , thuja occ. , vipera berus , echinacea , lappa , solidago , taraxacum , urtica ur. pelletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55714-4543 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Micrurus Corallinus Venom (UNII: V0S6H36980) (Micrurus Corallinus Venom - UNII:V0S6H36980) Micrurus Corallinus Venom 35 [hp_X] in 1 g Apis Mellifera (UNII: 7S82P3R43Z) (Apis Mellifera - UNII:7S82P3R43Z) Apis Mellifera 15 [hp_X] in 1 g Arsenic Trioxide (UNII: S7V92P67HO) (Arsenic Cation (3+) - UNII:C96613F5AV) Arsenic Trioxide 15 [hp_X] in 1 g Lytta Vesicatoria (UNII: 3Q034RO3BT) (Lytta Vesicatoria - UNII:3Q034RO3BT) Lytta Vesicatoria 15 [hp_X] in 1 g Cinchona Officinalis Bark (UNII: S003A158SB) (Cinchona Officinalis Bark - UNII:S003A158SB) Cinchona Officinalis Bark 15 [hp_X] in 1 g Colchicum Autumnale Bulb (UNII: 993QHL78E6) (Colchicum Autumnale Bulb - UNII:993QHL78E6) Colchicum Autumnale Bulb 15 [hp_X] in 1 g Convallaria Majalis (UNII: QHH4HVF5QE) (Convallaria Majalis - UNII:QHH4HVF5QE) Convallaria Majalis 15 [hp_X] in 1 g Crotalus Horridus Horridus Venom (UNII: YHA2XLJ956) (Crotalus Horridus Horridus Venom - UNII:YHA2XLJ956) Crotalus Horridus Horridus Venom 15 [hp_X] in 1 g Digitalis (UNII: F1T8QT9U8B) (Digitalis - UNII:F1T8QT9U8B) Digitalis 15 [hp_X] in 1 g Juniperus Communis Fruit (UNII: O84B5194RL) (Juniperus Communis Fruit - UNII:O84B5194RL) Juniperus Communis Fruit 15 [hp_X] in 1 g Lachesis Muta Venom (UNII: VSW71SS07I) (Lachesis Muta Venom - UNII:VSW71SS07I) Lachesis Muta Venom 15 [hp_X] in 1 g Mercury (UNII: FXS1BY2PGL) (Mercury - UNII:FXS1BY2PGL) Mercury 15 [hp_X] in 1 g Naja Naja Venom (UNII: ZZ4AG7L7VM) (Naja Naja Venom - UNII:ZZ4AG7L7VM) Naja Naja Venom 15 [hp_X] in 1 g Sodium Carbonate (UNII: 45P3261C7T) (Carbonate Ion - UNII:7UJQ5OPE7D) Sodium Carbonate 15 [hp_X] in 1 g Sodium Sulfate (UNII: 0YPR65R21J) (Sodium Sulfate Anhydrous - UNII:36KCS0R750) Sodium Sulfate 15 [hp_X] in 1 g Toxicodendron Pubescens Leaf (UNII: 6IO182RP7A) (Toxicodendron Pubescens Leaf - UNII:6IO182RP7A) Toxicodendron Pubescens Leaf 15 [hp_X] in 1 g Sambucus Nigra Flowering Top (UNII: CT03BSA18U) (Sambucus Nigra Flowering Top - UNII:CT03BSA18U) Sambucus Nigra Flowering Top 15 [hp_X] in 1 g Strophanthus Hispidus Seed (UNII: MO892VI77K) (Strophanthus Hispidus Seed - UNII:MO892VI77K) Strophanthus Hispidus Seed 15 [hp_X] in 1 g Thuja Occidentalis Leafy Twig (UNII: 1NT28V9397) (Thuja Occidentalis Leafy Twig - UNII:1NT28V9397) Thuja Occidentalis Leafy Twig 15 [hp_X] in 1 g Vipera Berus Venom (UNII: 0ORO6NCA4M) (Vipera Berus Venom - UNII:0ORO6NCA4M) Vipera Berus Venom 15 [hp_X] in 1 g Echinacea, Unspecified (UNII: 4N9P6CC1DX) (Echinacea, Unspecified - UNII:4N9P6CC1DX) Echinacea, Unspecified 8 [hp_X] in 1 g Arctium Lappa Root (UNII: 597E9BI3Z3) (Arctium Lappa Root - UNII:597E9BI3Z3) Arctium Lappa Root 8 [hp_X] in 1 g Solidago Virgaurea Flowering Top (UNII: 5405K23S50) (Solidago Virgaurea Flowering Top - UNII:5405K23S50) Solidago Virgaurea Flowering Top 8 [hp_X] in 1 g Taraxacum Officinale (UNII: 39981FM375) (Taraxacum Officinale - UNII:39981FM375) Taraxacum Officinale 8 [hp_X] in 1 g Urtica Urens (UNII: IHN2NQ5OF9) (Urtica Urens - UNII:IHN2NQ5OF9) Urtica Urens 8 [hp_X] in 1 g Inactive Ingredients Ingredient Name Strength Sucrose (UNII: C151H8M554) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55714-4543-1 28.35 g in 1 BOTTLE, GLASS 2 NDC:55714-4543-2 56.7 g in 1 BOTTLE, GLASS Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 06/01/2011 Labeler - Newton Laboratories, Inc. (788793610) Registrant - Newton Laboratories, Inc. (788793610) Establishment Name Address ID/FEI Business Operations Newton Laboratories, Inc. 788793610 MANUFACTURE(55714-4543)
