Edometriosis
- Manufacturer
- Newton Laboratories, Inc.
- Effective date
- 2011-06-01
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 3
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 01:37:22
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
INDICATIONS & USAGE SECTION
Endometriosis Formulated for associated symptoms such as menorrhagia, dysmenorrhea, dyspareunia and infertility.
DOSAGE & ADMINISTRATION 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. 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.
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.
KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
PACKAGE LABEL
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Apis Mellifera | ACTIVE INGREDIENT | 7S82P3R43Z | 3 | |
| Arsenic Trioxide | ACTIVE INGREDIENT | S7V92P67HO | 3 | |
| Black Cohosh | ACTIVE INGREDIENT | K73E24S6X9 | 3 | |
| Bryonia Alba Root | ACTIVE INGREDIENT | T7J046YI2B | 3 | |
| Cinchona Officinalis Bark | ACTIVE INGREDIENT | S003A158SB | 3 | |
| Claviceps Purpurea Sclerotium | ACTIVE INGREDIENT | 01G9XEA93N | 3 | |
| Conium Maculatum Flowering Top | ACTIVE INGREDIENT | Q28R5GF371 | 3 | |
| Goldenseal | ACTIVE INGREDIENT | ZW3Z11D0JV | 3 | |
| Hamamelis Virginiana Root Bark/stem Bark | ACTIVE INGREDIENT | T7S323PKJS | 3 | |
| Iodine | ACTIVE INGREDIENT | 9679TC07X4 | 3 | |
| Juniperus Sabina Leafy Twig | ACTIVE INGREDIENT | Z5BEX9K2G1 | 3 | |
| Lachesis Muta Venom | ACTIVE INGREDIENT | VSW71SS07I | 3 | |
| Lilium Lancifolium Whole Flowering | ACTIVE INGREDIENT | X67Z2963PI | 3 | |
| Lycopodium Clavatum Spore | ACTIVE INGREDIENT | C88X29Y479 | 3 | |
| Phosphorus | ACTIVE INGREDIENT | 27YLU75U4W | 3 | |
| Pulsatilla Vulgaris | ACTIVE INGREDIENT | I76KB35JEV | 3 | |
| Sepia Officinalis Juice | ACTIVE INGREDIENT | QDL83WN8C2 | 3 | |
| Toxicodendron Pubescens Leaf | ACTIVE INGREDIENT | 6IO182RP7A | 3 | |
| Apis Mellifera | ACTIVE MOIETY | 7S82P3R43Z | 3 | |
| Arsenic Cation (3+) | ACTIVE MOIETY | C96613F5AV | 3 | |
| Black Cohosh | ACTIVE MOIETY | K73E24S6X9 | 3 | |
| Bryonia Alba Root | ACTIVE MOIETY | T7J046YI2B | 3 | |
| Cinchona Officinalis Bark | ACTIVE MOIETY | S003A158SB | 3 | |
| Claviceps Purpurea Sclerotium | ACTIVE MOIETY | 01G9XEA93N | 3 | |
| Conium Maculatum Flowering Top | ACTIVE MOIETY | Q28R5GF371 | 3 | |
| Goldenseal | ACTIVE MOIETY | ZW3Z11D0JV | 3 | |
| Hamamelis Virginiana Root Bark/stem Bark | ACTIVE MOIETY | T7S323PKJS | 3 | |
| Iodine | ACTIVE MOIETY | 9679TC07X4 | 3 | |
| Juniperus Sabina Leafy Twig | ACTIVE MOIETY | Z5BEX9K2G1 | 3 | |
| Lachesis Muta Venom | ACTIVE MOIETY | VSW71SS07I | 3 | |
| Lilium Lancifolium Whole Flowering | ACTIVE MOIETY | X67Z2963PI | 3 | |
| Lycopodium Clavatum Spore | ACTIVE MOIETY | C88X29Y479 | 3 | |
| Phosphorus | ACTIVE MOIETY | 27YLU75U4W | 3 | |
| Pulsatilla Vulgaris | ACTIVE MOIETY | I76KB35JEV | 3 | |
| Sepia Officinalis Juice | ACTIVE MOIETY | QDL83WN8C2 | 3 | |
| Toxicodendron Pubescens Leaf | ACTIVE MOIETY | 6IO182RP7A | 3 | |
| Alcohol | INACTIVE INGREDIENT | 3K9958V90M | 3 |
Products#
Every source-derived product name is available through these pages.
- Edometriosis
- Arsenicum alb., Bryonia, Cimicifuga, Cinchona, Conium, Hydrastis, Iodium, Lachesis, Lilium, Lycopodium, Phosphorus, Pulsatilla, Rhus toxicodendron, Sabina, Secale, Sepia, Apis mel., Hamamelis
- Arsenic Trioxide
- Arsenic Cation (3+)
- 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
- Conium Maculatum Flowering Top
- Alcohol
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55714-4492 | 55714-4492-1, 55714-4492-2 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| Alcohol | ALCOHOL | 3K9958V90M | CAPSULE, EXTENDED RELEASE / ORAL | 8 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | AEROSOL, SPRAY / RESPIRATORY (INHALATION) | 35.75 %w/w | ||
| Alcohol | ALCOHOL | 3K9958V90M | LIQUID / ORAL | 3563 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | INJECTION, EMULSION / INTRAVENOUS | 520 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SHAMPOO / TOPICAL | 714 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SPRAY / TOPICAL | 3633 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | GEL / TOPICAL | 9971 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | AEROSOL, METERED / RESPIRATORY (INHALATION) | 26664 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | MOUTHWASH / BUCCAL | 200 mg/1ml | ||
| Alcohol | ALCOHOL | 3K9958V90M | SPRAY / NASAL | 20 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | INJECTION, SOLUTION / INTRAVENOUS | 6405 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | INJECTION / INTRAVENOUS | 92 %w/v | ||
| Alcohol | ALCOHOL | 3K9958V90M | DROPS / NASAL | 10 mg/1ml | ||
| Alcohol | ALCOHOL | 3K9958V90M | GEL / RECTAL | 898 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SOLUTION, CONCENTRATE / INTRAVENOUS | 4000 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | CONCENTRATE / ORAL | 198 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | TABLET, DELAYED RELEASE / ORAL | NA | ||
| Alcohol | ALCOHOL | 3K9958V90M | INJECTION / SUBCUTANEOUS | 149 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SOLUTION, CONCENTRATE / ORAL | 150.68 mg/1ml | ||
| Alcohol | ALCOHOL | 3K9958V90M | LIQUID / INTRAVENOUS | 400 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | AEROSOL, SPRAY / TOPICAL | 561 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | GEL / DENTAL | 1.8 %w/w | ||
| Alcohol | ALCOHOL | 3K9958V90M | PASTE / DENTAL | 1.8 %w/w | ||
| Alcohol | ALCOHOL | 3K9958V90M | INJECTION, SOLUTION / INTRAMUSCULAR | 1000 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | GEL, METERED / TOPICAL | 541 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | CONCENTRATE / BUCCAL | 679 mg/1ml | ||
| Alcohol | ALCOHOL | 3K9958V90M | SOLUTION / NASAL | 10 mg/1ml | ||
| Alcohol | ALCOHOL | 3K9958V90M | SOLUTION / OPHTHALMIC | 0.5 %w/v | ||
| Alcohol | ALCOHOL | 3K9958V90M | SOLUTION / ORAL | 6624 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | GEL / TRANSDERMAL | 7360 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | AEROSOL / TOPICAL | 561 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | AEROSOL / NASAL | 20 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | GEL, METERED / TRANSDERMAL | 3675 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | LIQUID / RESPIRATORY (INHALATION) | 5 %w/w | ||
| Alcohol | ALCOHOL | 3K9958V90M | DROPS / ORAL | 210 mg/1ml | ||
| Alcohol | ALCOHOL | 3K9958V90M | INJECTION / INTRAMUSCULAR | 1491 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SUSPENSION / ORAL | 681 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SOLUTION / INTRAVESICAL | 7892 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | INJECTION, SOLUTION / SUBCUTANEOUS | 6.1 %v/v | ||
| Alcohol | ALCOHOL | 3K9958V90M | LIQUID / INTRAMUSCULAR | 400 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SOLUTION / RESPIRATORY (INHALATION) | 0.08 %w/v | ||
| Alcohol | ALCOHOL | 3K9958V90M | SPRAY, METERED / SUBLINGUAL | 29 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SPRAY / TRANSDERMAL | 90 %w/v | ||
| Alcohol | ALCOHOL | 3K9958V90M | SOLUTION / TRANSDERMAL | 49.37 %w/v | ||
| Alcohol | ALCOHOL | 3K9958V90M | AEROSOL, METERED / NASAL | 70 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SUSPENSION / RECTAL | 0.35 %v/v | ||
| Alcohol | ALCOHOL | 3K9958V90M | SOLUTION / INTRAVENOUS | 99 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SWAB / TOPICAL | 2250 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | LOTION / TOPICAL | 25 %w/w | ||
| Alcohol | ALCOHOL | 3K9958V90M | ELIXIR / ORAL | 13675 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | JELLY / VAGINAL | NA | ||
| Alcohol | ALCOHOL | 3K9958V90M | INJECTION / INTRAVASCULAR | 100 %v/v | ||
| Alcohol | ALCOHOL | 3K9958V90M | CAPSULE / ORAL | 882 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | POWDER, FOR SOLUTION / TOPICAL | 40 %w/w | ||
| Alcohol | ALCOHOL | 3K9958V90M | SYRUP / ORAL | 21000 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | AEROSOL, FOAM / TOPICAL | 4504 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SOLUTION / TOPICAL | 2445 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SOLUTION / DENTAL | 12.8 %w/w | ||
| Alcohol | ALCOHOL | 3K9958V90M | SPRAY / SUBLINGUAL | 397 mg |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 98bdc970-2ec3-153d-e053-2a95a90a8a0f | 6958f8fc-2e02-211b-e933-d1f1a5351032 | 2019-12-02 | Warnings | 6958f8fc-2e02-211b-e933-d1f1a5351032 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
