Label: EDEMA - FLUID RETENTION- 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. liquid
- NDC Code(s): 55714-2432-0, 55714-2432-1, 55714-2432-2
- Packager: Newton Laboratories, 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 November 25, 2020
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- INDICATIONS & USAGE SECTION
- DOSAGE & ADMINISTRATION SECTION
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OTC - ACTIVE INGREDIENT SECTION
Equal parts of Echinacea 6x, Lappa 6x, Solidago 6x, Taraxacum 6x, urtica ur. 6x, Apis mel. 15x, Arsenicum alb. 15x, Cantharis 15x, Cinchona 15x, Colchicum 15x, Convallaria 15x, Crotalus hor. 15x, Digitalis 15x, Juniperus com.15x, Lachesis 15x, Merc. viv. 15x, Naja 15x, Nat. carb. 15x, Nat.sulphuricum 15x, Rhus tox. 15x, Sambucus nig. 15x, Strophanthus hisp. 15x, Thuja occ. 15x, Vipera 15x, Elaps 30x.
- OTC - PURPOSE SECTION
- INACTIVE INGREDIENT SECTION
- QUESTIONS SECTION
- WARNINGS SECTION
- OTC - PREGNANCY OR BREAST FEEDING SECTION
- OTC - KEEP OUT OF REACH OF CHILDREN SECTION
- PACKAGE LABEL
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INGREDIENTS AND APPEARANCE
EDEMA - FLUID RETENTION
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. liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55714-2432 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 30 [hp_X] in 1 mL APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA 15 [hp_X] in 1 mL ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE 15 [hp_X] in 1 mL LYTTA VESICATORIA (UNII: 3Q034RO3BT) (LYTTA VESICATORIA - UNII:3Q034RO3BT) LYTTA VESICATORIA 15 [hp_X] in 1 mL CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB) CINCHONA OFFICINALIS BARK 15 [hp_X] in 1 mL COLCHICUM AUTUMNALE BULB (UNII: 993QHL78E6) (COLCHICUM AUTUMNALE BULB - UNII:993QHL78E6) COLCHICUM AUTUMNALE BULB 15 [hp_X] in 1 mL CONVALLARIA MAJALIS (UNII: QHH4HVF5QE) (CONVALLARIA MAJALIS - UNII:QHH4HVF5QE) CONVALLARIA MAJALIS 15 [hp_X] in 1 mL CROTALUS HORRIDUS HORRIDUS VENOM (UNII: YHA2XLJ956) (CROTALUS HORRIDUS HORRIDUS VENOM - UNII:YHA2XLJ956) CROTALUS HORRIDUS HORRIDUS VENOM 15 [hp_X] in 1 mL DIGITALIS (UNII: F1T8QT9U8B) (DIGITALIS - UNII:F1T8QT9U8B) DIGITALIS 15 [hp_X] in 1 mL LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I) LACHESIS MUTA VENOM 15 [hp_X] in 1 mL MERCURY (UNII: FXS1BY2PGL) (MERCURY - UNII:FXS1BY2PGL) MERCURY 15 [hp_X] in 1 mL NAJA NAJA VENOM (UNII: ZZ4AG7L7VM) (NAJA NAJA VENOM - UNII:ZZ4AG7L7VM) NAJA NAJA VENOM 15 [hp_X] in 1 mL SODIUM CARBONATE (UNII: 45P3261C7T) (CARBONATE ION - UNII:7UJQ5OPE7D) SODIUM CARBONATE 15 [hp_X] in 1 mL SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM SULFATE ANHYDROUS - UNII:36KCS0R750) SODIUM SULFATE 15 [hp_X] in 1 mL TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF 15 [hp_X] in 1 mL SAMBUCUS NIGRA FLOWERING TOP (UNII: CT03BSA18U) (SAMBUCUS NIGRA FLOWERING TOP - UNII:CT03BSA18U) SAMBUCUS NIGRA FLOWERING TOP 15 [hp_X] in 1 mL STROPHANTHUS HISPIDUS SEED (UNII: MO892VI77K) (STROPHANTHUS HISPIDUS SEED - UNII:MO892VI77K) STROPHANTHUS HISPIDUS SEED 15 [hp_X] in 1 mL THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG 15 [hp_X] in 1 mL VIPERA BERUS VENOM (UNII: 0ORO6NCA4M) (VIPERA BERUS VENOM - UNII:0ORO6NCA4M) VIPERA BERUS VENOM 15 [hp_X] in 1 mL ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX) ECHINACEA, UNSPECIFIED 6 [hp_X] in 1 mL ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3) (ARCTIUM LAPPA ROOT - UNII:597E9BI3Z3) ARCTIUM LAPPA ROOT 6 [hp_X] in 1 mL SOLIDAGO VIRGAUREA FLOWERING TOP (UNII: 5405K23S50) (SOLIDAGO VIRGAUREA FLOWERING TOP - UNII:5405K23S50) SOLIDAGO VIRGAUREA FLOWERING TOP 6 [hp_X] in 1 mL TARAXACUM OFFICINALE (UNII: 39981FM375) (TARAXACUM OFFICINALE - UNII:39981FM375) TARAXACUM OFFICINALE 6 [hp_X] in 1 mL URTICA URENS (UNII: IHN2NQ5OF9) (URTICA URENS - UNII:IHN2NQ5OF9) URTICA URENS 6 [hp_X] in 1 mL JUNIPER BERRY (UNII: O84B5194RL) (JUNIPER BERRY - UNII:O84B5194RL) JUNIPER BERRY 15 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55714-2432-1 30 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 01/31/2019 2 NDC:55714-2432-2 50 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 01/31/2019 08/30/2019 3 NDC:55714-2432-0 15 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 01/31/2019 08/30/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 01/31/2019 Labeler - Newton Laboratories, Inc. (788793610) Registrant - Newton Laboratories, Inc. (788793610) Establishment Name Address ID/FEI Business Operations Newton Laboratories, Inc. 788793610 manufacture(55714-2432)
