EDEMA - FLUID RETENTION - micrurus corallinus venom, apis mellifera, arsenic trioxide, lytta vesicatoria, cinchona officinalis bark, colchicum autumnale bulb, convallaria majalis, crotalus horridus horridus venom, digitalis, juniperus communis fruit, lachesis muta venom, mercury, naja naja venom, sodium carbonate, sodium sulfate, toxicodendron pubescens leaf, sambucus nigra flowering top, strophanthus hispidus seed, thuja occidentalis leafy twig, vipera berus venom, echinacea, unspecified, arctium lappa root, solidago virgaurea flowering top, taraxacum officinale and urtica urens 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.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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INDICATIONS & USAGE SECTION

Edema - Fluid Retention  Formulated for associated symptoms such as skin discoloration, discomfort and swelling due to fluid retention.

DOSAGE & ADMINISTRATION SECTION

Directions: ORAL USE ONLY - SHAKE WELL.  Ages 12 and up, take 6 drops orally (ages 0 to 11, give 3 drops) one to four times daily or as directed by a healthcare professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

Elaps corallinus 30x, Apis mel. 10x, Arsenicum alb. 10x, Cantharis 10x, Cinchona 10x, Colchicum 10x, Convallaria 10x, Crotalus horridus 10x, Digitalis 10x, Juniperus com.10x, Lachesis 10x, Merc. viv. 10x, Naja 10x, Nat. carb. 10x, Nat.sulphuricum 10x, Rhus toxicodendron 10x, Sambucus nig. 10x, Strophanthus hispidus 10x, Thuja occ. 10x, Vipera berus 10x, Echinacea 3x, Lappa 3x, Solidago 3x, Taraxacum 3x, Urtica ur. 3x.

OTC - PURPOSE SECTION

Formulated for associated symptoms such as skin discoloration, discomfort and swelling due to fluid retention.

INACTIVE INGREDIENT SECTION

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

QUESTIONS SECTION

www.newtonlabs.net  Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
Questions?  1.800.448.7256 

WARNINGS SECTION

Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children.  

OTC - PREGNANCY OR BREAST FEEDING SECTION

Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

package 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
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55714-2328
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Micrurus Corallinus Venom (Micrurus Corallinus Venom) Micrurus Corallinus Venom30 [hp_X]  in 1 mL
Apis Mellifera (Apis Mellifera) Apis Mellifera10 [hp_X]  in 1 mL
Arsenic Trioxide (Arsenic Cation (3+)) Arsenic Trioxide10 [hp_X]  in 1 mL
Lytta Vesicatoria (Lytta Vesicatoria) Lytta Vesicatoria10 [hp_X]  in 1 mL
Cinchona Officinalis Bark (Cinchona Officinalis Bark) Cinchona Officinalis Bark10 [hp_X]  in 1 mL
Colchicum Autumnale Bulb (Colchicum Autumnale Bulb) Colchicum Autumnale Bulb10 [hp_X]  in 1 mL
Convallaria Majalis (Convallaria Majalis) Convallaria Majalis10 [hp_X]  in 1 mL
Crotalus Horridus Horridus Venom (Crotalus Horridus Horridus Venom) Crotalus Horridus Horridus Venom10 [hp_X]  in 1 mL
Digitalis (Digitalis) Digitalis10 [hp_X]  in 1 mL
Juniperus Communis Fruit (Juniper Berry) Juniperus Communis Fruit10 [hp_X]  in 1 mL
Lachesis Muta Venom (Lachesis Muta Venom) Lachesis Muta Venom10 [hp_X]  in 1 mL
Mercury (Mercury) Mercury10 [hp_X]  in 1 mL
Naja Naja Venom (Naja Naja Venom) Naja Naja Venom10 [hp_X]  in 1 mL
Sodium Carbonate (Carbonate Ion) Sodium Carbonate10 [hp_X]  in 1 mL
Sodium Sulfate (Sodium Sulfate Anhydrous) Sodium Sulfate10 [hp_X]  in 1 mL
Toxicodendron Pubescens Leaf (Toxicodendron Pubescens Leaf) Toxicodendron Pubescens Leaf10 [hp_X]  in 1 mL
Sambucus Nigra Flowering Top (Sambucus Nigra Flowering Top) Sambucus Nigra Flowering Top10 [hp_X]  in 1 mL
Strophanthus Hispidus Seed (Strophanthus Hispidus Seed) Strophanthus Hispidus Seed10 [hp_X]  in 1 mL
Thuja Occidentalis Leafy Twig (Thuja Occidentalis Leafy Twig) Thuja Occidentalis Leafy Twig10 [hp_X]  in 1 mL
Vipera Berus Venom (Vipera Berus Venom) Vipera Berus Venom10 [hp_X]  in 1 mL
Echinacea, Unspecified (Echinacea, Unspecified) Echinacea, Unspecified3 [hp_X]  in 1 mL
Arctium Lappa Root (Arctium Lappa Root) Arctium Lappa Root3 [hp_X]  in 1 mL
Solidago Virgaurea Flowering Top (Solidago Virgaurea Flowering Top) Solidago Virgaurea Flowering Top3 [hp_X]  in 1 mL
Taraxacum Officinale (Taraxacum Officinale) Taraxacum Officinale3 [hp_X]  in 1 mL
Urtica Urens (Urtica Urens) Urtica Urens3 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Alcohol 
Packaging
#Item CodePackage Description
1NDC:55714-2328-129.57 mL in 1 BOTTLE, GLASS
2NDC:55714-2328-259.14 mL in 1 BOTTLE, GLASS
3NDC:55714-2328-0.5 mL in 1 BOTTLE, GLASS
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic03/01/2011
Labeler - Newton Laboratories, Inc. (788793610)
Registrant - Newton Laboratories, Inc. (788793610)
Establishment
NameAddressID/FEIBusiness Operations
Newton Laboratories, Inc.788793610MANUFACTURE(55714-2328), API MANUFACTURE(55714-2328)

Revised: 03/2011
Document Id: 7dede351-4e37-0cb3-d4b4-53f5aff0f33e
Set id: dc6340b5-a026-44e6-01e2-d8541d59dfb3
Version: 1
Effective Time: 20110301
 
Newton Laboratories, Inc.