Edometriosis by Newton Laboratories, Inc. Endometriosis 4493P-Dis

Edometriosis by

Drug Labeling and Warnings

Edometriosis by is a Homeopathic medication manufactured, distributed, or labeled by Newton Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

EDOMETRIOSIS- arsenicum alb., bryonia, cimicifuga, cinchona, conium, hydrastis, iodium, lachesis, lilium, lycopodium, phosphorus, pulsatilla, rhus toxicodendron, sabina, secale, sepia, apis mel., hamamelis pellet 
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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Endometriosis 4493P-Dis

INDICATIONS & USAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions:   Ages 12 and up, take 6 pellets 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:  Gluten-free, non-GMO, beet-derived sucrose pellets.

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

EDOMETRIOSIS 
arsenicum alb., bryonia, cimicifuga, cinchona, conium, hydrastis, iodium, lachesis, lilium, lycopodium, phosphorus, pulsatilla, rhus toxicodendron, sabina, secale, sepia, apis mel., hamamelis pellet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 55714-4493
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV)	ARSENIC TRIOXIDE	10 [hp_X]  in 1 g
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	10 [hp_X]  in 1 g
BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9)	BLACK COHOSH	10 [hp_X]  in 1 g
CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB)	CINCHONA OFFICINALIS BARK	10 [hp_X]  in 1 g
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV)	GOLDENSEAL	10 [hp_X]  in 1 g
IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4)	IODINE	10 [hp_X]  in 1 g
LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I)	LACHESIS MUTA VENOM	10 [hp_X]  in 1 g
LILIUM LANCIFOLIUM WHOLE FLOWERING (UNII: X67Z2963PI) (LILIUM LANCIFOLIUM WHOLE FLOWERING - UNII:X67Z2963PI)	LILIUM LANCIFOLIUM WHOLE FLOWERING	10 [hp_X]  in 1 g
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479)	LYCOPODIUM CLAVATUM SPORE	10 [hp_X]  in 1 g
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	10 [hp_X]  in 1 g
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV)	PULSATILLA VULGARIS	10 [hp_X]  in 1 g
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A)	TOXICODENDRON PUBESCENS LEAF	10 [hp_X]  in 1 g
JUNIPERUS SABINA LEAFY TWIG (UNII: Z5BEX9K2G1) (JUNIPERUS SABINA LEAFY TWIG - UNII:Z5BEX9K2G1)	JUNIPERUS SABINA LEAFY TWIG	10 [hp_X]  in 1 g
CLAVICEPS PURPUREA SCLEROTIUM (UNII: 01G9XEA93N) (CLAVICEPS PURPUREA SCLEROTIUM - UNII:01G9XEA93N)	CLAVICEPS PURPUREA SCLEROTIUM	10 [hp_X]  in 1 g
SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2)	SEPIA OFFICINALIS JUICE	10 [hp_X]  in 1 g
APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z)	APIS MELLIFERA	3 [hp_X]  in 1 g
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - UNII:T7S323PKJS)	HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK	3 [hp_X]  in 1 g
CONIUM MACULATUM FLOWERING TOP (UNII: Q28R5GF371) (CONIUM MACULATUM FLOWERING TOP - UNII:Q28R5GF371)	CONIUM MACULATUM FLOWERING TOP	10 [hp_X]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SUCROSE (UNII: C151H8M554)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55714-4493-1	28.35 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	06/01/2011	09/02/2019
2	NDC: 55714-4493-2	56.7 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	06/01/2011	09/02/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		06/01/2011	09/02/2019

Labeler - Newton Laboratories, Inc. (788793610)

Registrant - Newton Laboratories, Inc. (788793610)

Establishment
Name	Address	ID/FEI	Business Operations
Newton Laboratories, Inc.		788793610	manufacture(55714-4493)

Revised: 12/2019

Document Id: 98bdc970-2ec4-153d-e053-2a95a90a8a0f

34391-3

Set id: cce9998b-1d26-04ae-ebd5-302be37b538a

Version: 2

Effective Time: 20191202