EDOMETRIOSIS - arsenic trioxide, bryonia alba root, black cohosh, cinchona officinalis bark, goldenseal, iodine, lachesis muta venom, lilium lancifolium whole flowering, lycopodium clavatum spore, phosphorus, pulsatilla vulgaris, toxicodendron pubescens leaf, juniperus sabina leafy twig, claviceps purpurea sclerotium, sepia officinalis juice, apis mellifera, hamamelis virginiana root bark/stem bark, goldenseal and conium maculatum flowering top 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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PRODUCT NAME & INDICATIONS SECTION

Endometriosis   Formulated for associated symptoms such as menorrhagia, dysmenorrhea, dyspareunia and infertility.

DIRECTION SECTION

Directions: ORAL USE ONLY - SHAKE WELL.  Ages 12 and up, take 6 drops orally one to four times daily or asdirected by a healthcare professional.

ACTIVE INGREDIENT SECTION

Arsenicum alb. 10x, Bryonia 10x, Cimicifuga 10x, Cinchona 10x, Conium 10x, Hydrastis 10x, Iodium 10x, Lachesis 10x, Lilium 10x, Lycopodium 10x, Phosphorus 10x, Pulsatilla 10x, Rhus toxicodendron 10x, Sabina 10x, Secale 10x, Sepia 10x, Apis mel. 3x, Hamamelis 3x, Hydrastis 3x.

PURPOSE SECTION

Formulated for associated symptoms such as menorrhagia, dysmenorrhea, dyspareunia and infertility.

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

EDOMETRIOSIS  
arsenicum alb., bryonia, cimicifuga, cinchona, conium, hydrastis, iodium, lachesis, lilium, lycopodium, phosphorus, pulsatilla, rhus toxicodendron, sabina, secale, sepia, apis mel., hamamelis, hydrastis liquid
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:55714-4492
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Arsenic Trioxide (Arsenic Cation (3+)) Arsenic Trioxide10 [hp_X]  in 1 mL
Bryonia Alba Root (Bryonia Alba Root) Bryonia Alba Root10 [hp_X]  in 1 mL
Black Cohosh (Black Cohosh) Black Cohosh10 [hp_X]  in 1 mL
Cinchona Officinalis Bark (Cinchona Officinalis Bark) Cinchona Officinalis Bark10 [hp_X]  in 1 mL
Goldenseal (Goldenseal) Goldenseal10 [hp_X]  in 1 mL
Iodine (Iodine) Iodine10 [hp_X]  in 1 mL
Lachesis Muta Venom (Lachesis Muta Venom) Lachesis Muta Venom10 [hp_X]  in 1 mL
Lilium Lancifolium Whole Flowering (Lilium Lancifolium Whole Flowering) Lilium Lancifolium Whole Flowering10 [hp_X]  in 1 mL
Lycopodium Clavatum Spore (Lycopodium Clavatum Spore) Lycopodium Clavatum Spore10 [hp_X]  in 1 mL
Phosphorus (Phosphorus) Phosphorus10 [hp_X]  in 1 mL
Pulsatilla Vulgaris (Pulsatilla Vulgaris) Pulsatilla Vulgaris10 [hp_X]  in 1 mL
Toxicodendron Pubescens Leaf (Toxicodendron Pubescens Leaf) Toxicodendron Pubescens Leaf10 [hp_X]  in 1 mL
Juniperus Sabina Leafy Twig (Juniperus Sabina Leafy Twig) Juniperus Sabina Leafy Twig10 [hp_X]  in 1 mL
Claviceps Purpurea Sclerotium (Claviceps Purpurea Sclerotium) Claviceps Purpurea Sclerotium10 [hp_X]  in 1 mL
Sepia Officinalis Juice (Sepia Officinalis Juice) Sepia Officinalis Juice10 [hp_X]  in 1 mL
Apis Mellifera (Apis Mellifera) Apis Mellifera3 [hp_X]  in 1 mL
Hamamelis Virginiana Root Bark/stem Bark (Hamamelis Virginiana Root Bark/stem Bark) Hamamelis Virginiana Root Bark/stem Bark3 [hp_X]  in 1 mL
Goldenseal (Goldenseal) Goldenseal3 [hp_X]  in 1 mL
Conium Maculatum Flowering Top (Conium Maculatum Flowering Top) Conium Maculatum Flowering Top10 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Alcohol 
Packaging
#Item CodePackage Description
1NDC:55714-4492-129.57 mL in 1 BOTTLE, GLASS
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic06/01/2011
Labeler - Newton Laboratories, Inc. (788793610)
Registrant - Newton Laboratories, Inc. (788793610)
Establishment
NameAddressID/FEIBusiness Operations
Newton Laboratories, Inc.788793610MANUFACTURE(55714-4492), API MANUFACTURE(55714-4492)

Revised: 06/2011
Document Id: 8705a2c7-36cd-f35e-64e9-e4ecac32b100
Set id: 6958f8fc-2e02-211b-e933-d1f1a5351032
Version: 1
Effective Time: 20110601
 
Newton Laboratories, Inc.