FEMALE FIBROIDS - arsenic trioxide, calcium iodide, carbo animalis, conium maculatum flowering top, graphite, goldenseal, iodine, wood creosote, lachesis muta venom, phosphorus, juniperus sabina leafy twig, claviceps purpurea sclerotium, sepia officinalis juice, silicon dioxide, capsella bursa-pastoris, thuja occidentalis leafy twig, thyroid, unspecified, trillium erectum root, ustilago maydis, goldenseal and thuja occidentalis leafy twig 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

FEMALE FIBROIDS  Formulated for symptoms associated with non-malignant uterine or ovarian fibroids, ovarian or vaginal cysts and uterine polyps.      

DIRECTION SECTION

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

ACTIVE INGREDIENT SECTION

Arsenicum alb. 15x, Calcarea iodata 15x, Carbo animalis 15x, Conium 15x, Graphites 15x, Hydrastis 15x,  Iodium 15x, Kreosotum 15x, Lachesis 15x, Phosphorus 15x, Sabina 15x, Secale 15x, Sepia 15x, Silicea 15x, Thlaspi  15x, Thuja occ. 15x, Thyroidinum 15x, Trillium pendulum 15x, Ustilago maidis 15x, Hydrastis 3x, Thuja occ. 3x.          

PURPOSE SECTION

Formulated for symptoms associated with non-malignant uterine or ovarian fibroids, ovarian or vaginal cysts and uterine polyps.

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 or 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

FEMALE FIBROIDS  
arsenicum alb., clacarea iodata, carbo animalis, conium, graphites, hydrastis, iodium, kreosotum, lachesis, phosphorus, sabina, secale, sepia, silicea, thlaspi, thuja occ., thyroidinum, trillium pendulum, ustilago maidis, hydrastis, liquid
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:55714-4592
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Arsenic Trioxide (Arsenic Cation (3+)) Arsenic Trioxide15 [hp_X]  in 1 mL
Calcium Iodide (Calcium Cation) Calcium Iodide15 [hp_X]  in 1 mL
Carbo Animalis (Carbo Animalis) Carbo Animalis15 [hp_X]  in 1 mL
Conium Maculatum Flowering Top (Conium Maculatum Flowering Top) Conium Maculatum Flowering Top15 [hp_X]  in 1 mL
Graphite (Graphite) Graphite15 [hp_X]  in 1 mL
Goldenseal (Goldenseal) Goldenseal15 [hp_X]  in 1 mL
Iodine (Iodine) Iodine15 [hp_X]  in 1 mL
Wood Creosote (Wood Creosote) Wood Creosote15 [hp_X]  in 1 mL
Lachesis Muta Venom (Lachesis Muta Venom) Lachesis Muta Venom15 [hp_X]  in 1 mL
Phosphorus (Phosphorus) Phosphorus15 [hp_X]  in 1 mL
Juniperus Sabina Leafy Twig (Juniperus Sabina Leafy Twig) Juniperus Sabina Leafy Twig15 [hp_X]  in 1 mL
Claviceps Purpurea Sclerotium (Claviceps Purpurea Sclerotium) Claviceps Purpurea Sclerotium15 [hp_X]  in 1 mL
Sepia Officinalis Juice (Sepia Officinalis Juice) Sepia Officinalis Juice15 [hp_X]  in 1 mL
Silicon Dioxide (Silicon Dioxide) Silicon Dioxide15 [hp_X]  in 1 mL
Capsella Bursa-pastoris (Capsella Bursa-pastoris) Capsella Bursa-pastoris15 [hp_X]  in 1 mL
Thuja Occidentalis Leafy Twig (Thuja Occidentalis Leafy Twig) Thuja Occidentalis Leafy Twig15 [hp_X]  in 1 mL
Thyroid, Unspecified (Thyroid, Unspecified) Thyroid, Unspecified15 [hp_X]  in 1 mL
Trillium Erectum Root (Trillium Erectum Root) Trillium Erectum Root15 [hp_X]  in 1 mL
Ustilago Maydis (Ustilago Maydis) Ustilago Maydis15 [hp_X]  in 1 mL
Goldenseal (Goldenseal) Goldenseal3 [hp_X]  in 1 mL
Thuja Occidentalis Leafy Twig (Thuja Occidentalis Leafy Twig) Thuja Occidentalis Leafy Twig3 [hp_X]  in 1 mL
Packaging
#Item CodePackage Description
1NDC:55714-4592-129.57 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(55714-4592), API MANUFACTURE(55714-4592)

Revised: 06/2011
Document Id: bf9e87bd-7d51-696e-37ae-20cccca0a6ea
Set id: 3e3a703b-7fe3-7b9e-478e-f18638f65240
Version: 1
Effective Time: 20110601
 
Newton Laboratories, Inc.