NEORELIEF FOR MENSTRUAL PAIN AND CRAMPS- homeopathic pain relief gel gel

NeoRelief for Menstrual Pain and Cramps by

Drug Labeling and Warnings

NeoRelief for Menstrual Pain and Cramps by is a Homeopathic medication manufactured, distributed, or labeled by BioLyte Laboratories, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

Purpose

Topical Analgesics

Relief of Cramping

Anti-inflammatory

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

Warnings

Stop use and ask doctor if:

Condition worsens or persists,

rash develops

Warnings

If pregnant or breastfeeding consult your doctor before use.

Warnings

Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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

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)

INGREDIENTS AND APPEARANCE

NEORELIEF FOR MENSTRUAL PAIN AND CRAMPS 
homeopathic pain relief gel gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58368-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POTASSIUM CARBONATE (UNII: BQN1B9B9HA) (CARBONATE ION - UNII:7UJQ5OPE7D)	POTASSIUM CARBONATE	4 [hp_X]  in 1 g
FRANGULA CALIFORNICA BARK (UNII: 1LZ13MQR0S) (FRANGULA CALIFORNICA BARK - UNII:1LZ13MQR0S)	FRANGULA CALIFORNICA BARK	4 [hp_X]  in 1 g
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	4 [hp_X]  in 1 g
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	4 [hp_X]  in 1 g
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	4 [hp_X]  in 1 g
BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9)	BLACK COHOSH	4 [hp_X]  in 1 g
CYCLAMEN PURPURASCENS TUBER (UNII: G728143D8Q) (CYCLAMEN PURPURASCENS TUBER - UNII:G728143D8Q)	CYCLAMEN PURPURASCENS TUBER	4 [hp_X]  in 1 g
SARACA INDICA BARK (UNII: 341ALE870W) (SARACA INDICA BARK - UNII:341ALE870W)	SARACA INDICA BARK	4 [hp_X]  in 1 g
LILIUM LANCIFOLIUM WHOLE FLOWERING (UNII: X67Z2963PI) (LILIUM LANCIFOLIUM WHOLE FLOWERING - UNII:X67Z2963PI)	LILIUM LANCIFOLIUM WHOLE FLOWERING	4 [hp_X]  in 1 g
JUNIPERUS SABINA LEAFY TWIG (UNII: Z5BEX9K2G1) (JUNIPERUS SABINA LEAFY TWIG - UNII:Z5BEX9K2G1)	JUNIPERUS SABINA LEAFY TWIG	4 [hp_X]  in 1 g
BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY)	BELLIS PERENNIS	4 [hp_X]  in 1 g
SELENICEREUS GRANDIFLORUS STEM (UNII: 7114SV0MYK) (SELENICEREUS GRANDIFLORUS STEM - UNII:7114SV0MYK)	SELENICEREUS GRANDIFLORUS STEM	4 [hp_X]  in 1 g
CAULOPHYLLUM THALICTROIDES ROOT (UNII: JTJ6HH6YEH) (CAULOPHYLLUM THALICTROIDES ROOT - UNII:JTJ6HH6YEH)	CAULOPHYLLUM THALICTROIDES ROOT	4 [hp_X]  in 1 g
CITRULLUS COLOCYNTHIS FRUIT PULP (UNII: 23H32AOH17) (CITRULLUS COLOCYNTHIS FRUIT PULP - UNII:23H32AOH17)	CITRULLUS COLOCYNTHIS FRUIT PULP	4 [hp_X]  in 1 g
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q)	GELSEMIUM SEMPERVIRENS ROOT	4 [hp_X]  in 1 g
VIBURNUM OPULUS BARK (UNII: T1UG6H6805) (VIBURNUM OPULUS BARK - UNII:T1UG6H6805)	VIBURNUM OPULUS BARK	4 [hp_X]  in 1 g
TILIA X EUROPAEA FLOWER (UNII: NHV2K1OUDH) (TILIA X EUROPAEA FLOWER - UNII:NHV2K1OUDH)	TILIA X EUROPAEA FLOWER	4 [hp_X]  in 1 g
APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z)	APIS MELLIFERA	4 [hp_X]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
FULVIC ACID (UNII: XII14C5FXV)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58368-003-03	14.17 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/27/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		04/27/2018

Labeler - BioLyte Laboratories, LLC (015560564)

Establishment
Name	Address	ID/FEI	Business Operations
BioLyte Laboratories, LLC		015560564	label(58368-003) , manufacture(58368-003)