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. liquid 
Newton Laboratories, Inc.

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.

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Edema 4812L

INDICATIONS & USAGE SECTION

Formulated for smptoms such as skin discoloration, discomfort and swelling.

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) one to four times daily or as directed by a health professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Echinacea 11x, Lappa 11x, Solidago 11x, Taraxacum 11x, Urtica ur. 11x, Apis mel. 20x, Arsenicum alb. 20x, Cantharis 20x, Cinchona 20x, Colchicum 20x, Convallaria 20x, Crotalus hor. 20x, Digitalis 20x, Juniperus com. 20x, Lachesis 20x, Merc. viv. 20x, Naja 20x, Nat. carb. 20x, Nat.sulphuricum 20x, Rhus tox. 20x, Sambucus nig. 20x, Strophanthus hisp. 20x, Thuja occ. 20x, Vipera 20x, Elaps 35x.

OTC - PURPOSE SECTION

Formulated for symptoms such as skin discoloration, discomfort and swelling.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane alcohol 20%.

QUESTIONS SECTION

newtonlabs.net - Questions? 800.448.7256

Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

WARNINGS SECTION

WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding, ask a doctor before use.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a doctor before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

package 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. liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55714-4812
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICRURUS CORALLINUS VENOM (UNII: V0S6H36980) (MICRURUS CORALLINUS VENOM - UNII:V0S6H36980) MICRURUS CORALLINUS VENOM35 [hp_X]  in 1 mL
APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA20 [hp_X]  in 1 mL
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE20 [hp_X]  in 1 mL
LYTTA VESICATORIA (UNII: 3Q034RO3BT) (LYTTA VESICATORIA - UNII:3Q034RO3BT) LYTTA VESICATORIA20 [hp_X]  in 1 mL
CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB) CINCHONA OFFICINALIS BARK20 [hp_X]  in 1 mL
COLCHICUM AUTUMNALE BULB (UNII: 993QHL78E6) (COLCHICUM AUTUMNALE BULB - UNII:993QHL78E6) COLCHICUM AUTUMNALE BULB20 [hp_X]  in 1 mL
CONVALLARIA MAJALIS (UNII: QHH4HVF5QE) (CONVALLARIA MAJALIS - UNII:QHH4HVF5QE) CONVALLARIA MAJALIS20 [hp_X]  in 1 mL
CROTALUS HORRIDUS HORRIDUS VENOM (UNII: YHA2XLJ956) (CROTALUS HORRIDUS HORRIDUS VENOM - UNII:YHA2XLJ956) CROTALUS HORRIDUS HORRIDUS VENOM20 [hp_X]  in 1 mL
NAJA NAJA VENOM (UNII: ZZ4AG7L7VM) (NAJA NAJA VENOM - UNII:ZZ4AG7L7VM) NAJA NAJA VENOM20 [hp_X]  in 1 mL
DIGITALIS (UNII: F1T8QT9U8B) (DIGITALIS - UNII:F1T8QT9U8B) DIGITALIS20 [hp_X]  in 1 mL
LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I) LACHESIS MUTA VENOM20 [hp_X]  in 1 mL
MERCURY (UNII: FXS1BY2PGL) (MERCURY - UNII:FXS1BY2PGL) MERCURY20 [hp_X]  in 1 mL
SODIUM CARBONATE (UNII: 45P3261C7T) (CARBONATE ION - UNII:7UJQ5OPE7D) SODIUM CARBONATE20 [hp_X]  in 1 mL
SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM SULFATE ANHYDROUS - UNII:36KCS0R750) SODIUM SULFATE20 [hp_X]  in 1 mL
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF20 [hp_X]  in 1 mL
SAMBUCUS NIGRA FLOWERING TOP (UNII: CT03BSA18U) (SAMBUCUS NIGRA FLOWERING TOP - UNII:CT03BSA18U) SAMBUCUS NIGRA FLOWERING TOP20 [hp_X]  in 1 mL
STROPHANTHUS HISPIDUS SEED (UNII: MO892VI77K) (STROPHANTHUS HISPIDUS SEED - UNII:MO892VI77K) STROPHANTHUS HISPIDUS SEED20 [hp_X]  in 1 mL
THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG20 [hp_X]  in 1 mL
VIPERA BERUS VENOM (UNII: 0ORO6NCA4M) (VIPERA BERUS VENOM - UNII:0ORO6NCA4M) VIPERA BERUS VENOM20 [hp_X]  in 1 mL
ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX) ECHINACEA, UNSPECIFIED11 [hp_X]  in 1 mL
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3) (ARCTIUM LAPPA ROOT - UNII:597E9BI3Z3) ARCTIUM LAPPA ROOT11 [hp_X]  in 1 mL
SOLIDAGO VIRGAUREA FLOWERING TOP (UNII: 5405K23S50) (SOLIDAGO VIRGAUREA FLOWERING TOP - UNII:5405K23S50) SOLIDAGO VIRGAUREA FLOWERING TOP11 [hp_X]  in 1 mL
TARAXACUM OFFICINALE (UNII: 39981FM375) (TARAXACUM OFFICINALE - UNII:39981FM375) TARAXACUM OFFICINALE11 [hp_X]  in 1 mL
URTICA URENS (UNII: IHN2NQ5OF9) (URTICA URENS - UNII:IHN2NQ5OF9) URTICA URENS11 [hp_X]  in 1 mL
JUNIPER BERRY (UNII: O84B5194RL) (JUNIPER BERRY - UNII:O84B5194RL) JUNIPER BERRY20 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55714-4812-130 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product09/02/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic09/02/2019
Labeler - Newton Laboratories, Inc. (788793610)
Registrant - Newton Laboratories, Inc. (788793610)
Establishment
NameAddressID/FEIBusiness Operations
Newton Laboratories, Inc.788793610manufacture(55714-4812)

Revised: 12/2020
Document Id: b5924b1f-3082-cd6e-e053-2a95a90ac950
Set id: 98fbd4b0-43ac-098b-e053-2a95a90a6645
Version: 2
Effective Time: 20201203
 
Newton Laboratories, Inc.