SPL v9
SPL
SPL Set ID 71c2a2f7-4823-51cb-e053-2995a90a5fb8
Route
TOPICAL
Published
Effective Date 2018-04-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Carbonate Ion (4 [hp_X]) Frangula Californica Bark Arnica Montana Atropa Belladonna Bryonia Alba Root Black Cohosh Cyclamen Purpurascens Tuber Saraca Indica Bark Lilium Lancifolium Whole Flowering Juniperus Sabina Leafy Twig Bellis Perennis Selenicereus Grandiflorus Stem Caulophyllum Thalictroides Root Citrullus Colocynthis Fruit Pulp Gelsemium Sempervirens Root Viburnum Opulus Bark Tilia X Europaea Flower Apis Mellifera
Inactive Ingredients
Potassium Sorbate Sodium Hydroxide Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked) Fulvic Acid Glycerin Water Citric Acid Monohydrate

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2018-04-27

Description

All actives are HPUS* and 4X potency. Apis, Arnica, Belladonna, Bryonia, Cimicifuga, Cyclamen, Joneosia, Kali Carb., Lilium, Rhamnus Calif., Sabina Bellis, Cactus, Caulophyllum, Colocynthis, Gelsemium, Viburnum Tilia *HPUS indicates the active ingredients are inthe official Homeopathic Pharmacopeia of the United States.

Purpose

Topical Analgesics Relief of Cramping Anti-inflammatory


Medication Information

Purpose

Topical Analgesics

Relief of Cramping

Anti-inflammatory

Description

All actives are HPUS* and 4X potency. Apis, Arnica, Belladonna, Bryonia, Cimicifuga, Cyclamen, Joneosia, Kali Carb., Lilium, Rhamnus Calif., Sabina Bellis, Cactus, Caulophyllum, Colocynthis, Gelsemium, Viburnum Tilia *HPUS indicates the active ingredients are inthe official Homeopathic Pharmacopeia of the United States.

Uses

For temporary relief of menstrual symptoms such as:

Menstrual pain, Cramping

Indications are based on homeopathic materia medica, not clinical tests.

Warnings

For external use only

Do not use on damged or broken skin.

Keep out of eyes, open wounds, mucous membranes

Directions

Women ages 8 years and older, spread thin layer on lower abdomen and lower back.

Do not apply over other topical lotions; they may hinder effectiveness.

Apply as needed for relief.

Other Information

Store in a cool, dry place. Avoid direct sunlight. Tamper-evident for your protection. Use only if safety seal is intact.

Inactive Ingredients

Citric Acid, Fulvic Acid, Glycerin, Potassium Sorbate, Purified Water, Sodium Hydroxide, Ultrez-10 Polymer.

Questions Or Comments?

800.538.1455

Monday through Friday, 8 a.m. - 5 p.m. EST or visit us at neorelief.com.

Reporty any serious side effects to the number above.

Addtional Label Content

Packaging Recyclable

Made in the USA

Listed with the FDA

neorelief.com

Drug Facts continued peel here

FTC required disclosure: Product efficacy and claims are based on theories of homeopathy that re not supported by scientific evidence and most modern allopathic medical professionals.

BioLyte Labs Grand Rapids, MI 49534

Drug Facts Active Ingredients

All actives are HPUS* and 4X potency.

Apis, Arnica, Belladonna, Bryonia, Cimicifuga, Cyclamen, Joneosia, Kali Carb., Lilium, Rhamnus Calif., Sabina

Bellis, Cactus, Caulophyllum, Colocynthis, Gelsemium, Viburnum

Tilia

*HPUS indicates the active ingredients are inthe official Homeopathic Pharmacopeia of the United States.

Neorelief for Menstrual Pain and Cramps

NDC 58368-003-03 Patent Pending

Neo Relief

Temporary relief of

Menstrual pain & cramps

Homeopathic pain relief gel

Net Wt. 0.5 oz (14.17g)


Structured Label Content

Uses

For temporary relief of menstrual symptoms such as:

Menstrual pain, Cramping

Indications are based on homeopathic materia medica, not clinical tests.

Purpose

Topical Analgesics

Relief of Cramping

Anti-inflammatory

Warnings

For external use only

Do not use on damged or broken skin.

Keep out of eyes, open wounds, mucous membranes

Directions

Women ages 8 years and older, spread thin layer on lower abdomen and lower back.

Do not apply over other topical lotions; they may hinder effectiveness.

Apply as needed for relief.

Other Information

Store in a cool, dry place. Avoid direct sunlight. Tamper-evident for your protection. Use only if safety seal is intact.

Inactive Ingredients

Citric Acid, Fulvic Acid, Glycerin, Potassium Sorbate, Purified Water, Sodium Hydroxide, Ultrez-10 Polymer.

Questions Or Comments? (Questions or Comments?)

800.538.1455

Monday through Friday, 8 a.m. - 5 p.m. EST or visit us at neorelief.com.

Reporty any serious side effects to the number above.

Addtional Label Content

Packaging Recyclable

Made in the USA

Listed with the FDA

neorelief.com

Drug Facts continued peel here

FTC required disclosure: Product efficacy and claims are based on theories of homeopathy that re not supported by scientific evidence and most modern allopathic medical professionals.

BioLyte Labs Grand Rapids, MI 49534

Drug Facts Active Ingredients

All actives are HPUS* and 4X potency.

Apis, Arnica, Belladonna, Bryonia, Cimicifuga, Cyclamen, Joneosia, Kali Carb., Lilium, Rhamnus Calif., Sabina

Bellis, Cactus, Caulophyllum, Colocynthis, Gelsemium, Viburnum

Tilia

*HPUS indicates the active ingredients are inthe official Homeopathic Pharmacopeia of the United States.

Neorelief for Menstrual Pain and Cramps (NEORELIEF for Menstrual Pain and Cramps)

NDC 58368-003-03 Patent Pending

Neo Relief

Temporary relief of

Menstrual pain & cramps

Homeopathic pain relief gel

Net Wt. 0.5 oz (14.17g)


Advanced Ingredient Data


Raw Label Data

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