FEMALE FEMROIDS- hydrastis canadensis, thuja occidentalis, arsenicum album, calcarea iodata, carbo animalis, conium maculatum, graphites, hydrastis canadensis, iodium, kreosotum, lachesis mutus, phosphorus, sabina, secale cornutum, sepia, silicea, thlaspi bursa-pastoris, thuja occidentalis, thyroidinum, trillium pendulum, ustilago maidis. 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.

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Female 4769L

INDICATIONS & USAGE SECTION

Formulated for symptoms such as heavy or prolonged menses and/or pelvic discomfort.

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 drops by mouth one to four times daily or as directed by a health professional

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Hydrastis canadensis 6x, Thuja occidentalis 6x, Arsenicum album 15x, Calcarea iodata 15x, Carbo animalis 15x, Conium maculatum 15x, Graphites 15x, Hydrastis canadensis 15x, Iodium 15x, Kreosotum 15x, Lachesis mutus 15x, Phosphorus 15x, Sabina 15x, Secale cornutum 15x, Sepia 15x, Silicea 15x, Thlaspi bursa-pastoris 15x, Thuja occidentalis 15x, Thyroidinum 15x, Trillium pendulum 15x, Ustilago maidis 1

OTC - PURPOSE SECTION

Formulated for symptoms such as heavy or prolonged menses and/or pelvic discomfort.

INACTIVE INGREDIENT SECTION

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

QUESTIONS SECTION

newtonlabs.net - Questions? 800.448.7256

Newton Laboratories, Inc. FDA Est # 1051203 Conyers, GA 30013

WARNINGS SECTION

WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding, ask a doctor before use.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a doctor before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

package label

FEMALE FEMROIDS
hydrastis canadensis, thuja occidentalis, arsenicum album, calcarea iodata, carbo animalis, conium maculatum, graphites, hydrastis canadensis, iodium, kreosotum, lachesis mutus, phosphorus, sabina, secale cornutum, sepia, silicea, thlaspi bursa-pastoris, thuja occidentalis, thyroidinum, trillium pendulum, ustilago maidis. liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55714-4769
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV)	GOLDENSEAL	15 [hp_X] in 1 mL
USTILAGO MAYDIS (UNII: 4K7Z7K7SWG) (USTILAGO MAYDIS - UNII:4K7Z7K7SWG)	USTILAGO MAYDIS	15 [hp_X] in 1 mL
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV)	ARSENIC TRIOXIDE	15 [hp_X] in 1 mL
CALCIUM IODIDE (UNII: 8EKI9QEE2H) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM IODIDE	15 [hp_X] in 1 mL
CARBO ANIMALIS (UNII: 279O8I0433) (CARBO ANIMALIS - UNII:279O8I0433)	CARBO ANIMALIS	15 [hp_X] in 1 mL
CONIUM MACULATUM FLOWERING TOP (UNII: Q28R5GF371) (CONIUM MACULATUM FLOWERING TOP - UNII:Q28R5GF371)	CONIUM MACULATUM FLOWERING TOP	15 [hp_X] in 1 mL
GRAPHITE (UNII: 4QQN74LH4O) (GRAPHITE - UNII:4QQN74LH4O)	GRAPHITE	15 [hp_X] in 1 mL
IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4)	IODINE	15 [hp_X] in 1 mL
WOOD CREOSOTE (UNII: 3JYG22FD73) (WOOD CREOSOTE - UNII:3JYG22FD73)	WOOD CREOSOTE	15 [hp_X] in 1 mL
LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I)	LACHESIS MUTA VENOM	15 [hp_X] in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	15 [hp_X] in 1 mL
JUNIPERUS SABINA LEAFY TWIG (UNII: Z5BEX9K2G1) (JUNIPERUS SABINA LEAFY TWIG - UNII:Z5BEX9K2G1)	JUNIPERUS SABINA LEAFY TWIG	15 [hp_X] in 1 mL
CLAVICEPS PURPUREA SCLEROTIUM (UNII: 01G9XEA93N) (CLAVICEPS PURPUREA SCLEROTIUM - UNII:01G9XEA93N)	CLAVICEPS PURPUREA SCLEROTIUM	15 [hp_X] in 1 mL
SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2)	SEPIA OFFICINALIS JUICE	15 [hp_X] in 1 mL
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	15 [hp_X] in 1 mL
CAPSELLA BURSA-PASTORIS (UNII: W0X9457M59) (CAPSELLA BURSA-PASTORIS - UNII:W0X9457M59)	CAPSELLA BURSA-PASTORIS	15 [hp_X] in 1 mL
THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397)	THUJA OCCIDENTALIS LEAFY TWIG	15 [hp_X] in 1 mL
THYROID, UNSPECIFIED (UNII: 0B4FDL9I6P) (THYROID, UNSPECIFIED - UNII:0B4FDL9I6P)	THYROID, UNSPECIFIED	15 [hp_X] in 1 mL
TRILLIUM ERECTUM ROOT (UNII: AHW6F0T2X0) (TRILLIUM ERECTUM ROOT - UNII:AHW6F0T2X0)	TRILLIUM ERECTUM ROOT	15 [hp_X] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55714-4769-1	30 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	09/02/2019

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

Labeler - Newton Laboratories, Inc. (788793610)

Registrant - Newton Laboratories, Inc. (788793610)

Name	Address	ID/FEI	Business Operations
Establishment
Newton Laboratories, Inc.		788793610	manufacture(55714-4769)