NEORELIEF FOR MUSCLE CRAMPLING AND RESTLESSNESS- topical gel for muscle cramping and restlessness gel

NEORELIEF FOR MUSCLE CRAMPLING AND RESTLESSNESS by

Drug Labeling and Warnings

NEORELIEF FOR MUSCLE CRAMPLING AND RESTLESSNESS 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 active ingredients are HPUS*

Arncia 4X, Causticum 4X, Rhamnus Calif. 4X, Ruta 4X, Taraxacum 4X,

Belladonna 4X, Cimicifuga 4X, Gnaphalium 4X, Hypericum Perf. 4X, Jatropha 8X, Veratrum 8X

Cina 8X, Ignatia 4X, Kali Brom. 4X, Kali Carb. 4X, Lycopodium 4X, Scutellaria 4X, Valeriana Off. 4X

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

Purpose

For the temporary relief of occasional:

Muscle cramps, restlessness, twiching

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

Uses

For temporary relief of occasional muscle cramps, restlessness and twitching

Warnings

For external use only

Do not use on damaged 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

Ask a doctor before use if you are taking a prescription drug or have a serious medical condition.

Warnings

If pregnant or breast-feeding, 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

Adults and children 2 years of age and older, apply a thin layer of gel on clean skin to cover the affected area.

For best results, allow gel to be absorbed into the skin; do not rub in.

Apply at the onset of symptoms, not more than 6 times daily or every 15 minutes for the first hour.

Do not use with other topical remedies or lotions.

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

Report serious side effects to 800.538.1455

Additional Label Content

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

Made in the USA

Listed with the FDA

(UPC code: 3 58368 00202 1)

Drug Facts continued peel here

Packaging Recyclable

neorelief.com

BioLyte Laboratories- Grand Rapids, MI 49534

NEORELIEF for Muscle Cramping and Restlessness 56.7 g Bottle

NDC: 58368-002-02 Patent pending

NeoRelief

Temporary relief of muscle cramping and restlessness

Homeopathic muscle calming and pain relief gel

Net Wt. 2.0 oz (56.7g)

INGREDIENTS AND APPEARANCE

NEORELIEF FOR MUSCLE CRAMPLING AND RESTLESSNESS 
topical gel for muscle cramping and restlessness gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58368-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU)	CAUSTICUM	4 [hp_X]  in 1 g
JATROPHA CURCAS SEED (UNII: J0F5GM8LA8) (JATROPHA CURCAS SEED - UNII:J0F5GM8LA8)	JATROPHA CURCAS SEED	8 [hp_X]  in 1 g
FRANGULA CALIFORNICA BARK (UNII: 1LZ13MQR0S) (FRANGULA CALIFORNICA BARK - UNII:1LZ13MQR0S)	FRANGULA CALIFORNICA BARK	4 [hp_X]  in 1 g
RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S)	RUTA GRAVEOLENS FLOWERING TOP	4 [hp_X]  in 1 g
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	4 [hp_X]  in 1 g
ATROPA BELLADONNA ROOT (UNII: 6MW97Q6E8M) (ATROPA BELLADONNA ROOT - UNII:6MW97Q6E8M)	ATROPA BELLADONNA ROOT	4 [hp_X]  in 1 g
BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9)	BLACK COHOSH	4 [hp_X]  in 1 g
ARTEMISIA CINA PRE-FLOWERING TOP (UNII: 28M1820ACT) (ARTEMISIA CINA PRE-FLOWERING TOP - UNII:28M1820ACT)	ARTEMISIA CINA PRE-FLOWERING TOP	8 [hp_X]  in 1 g
PSEUDOGNAPHALIUM OBTUSIFOLIUM (UNII: 36XQ854NWW) (PSEUDOGNAPHALIUM OBTUSIFOLIUM - UNII:36XQ854NWW)	PSEUDOGNAPHALIUM OBTUSIFOLIUM	4 [hp_X]  in 1 g
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB)	HYPERICUM PERFORATUM	4 [hp_X]  in 1 g
STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K)	STRYCHNOS IGNATII SEED	4 [hp_X]  in 1 g
POTASSIUM BROMIDE (UNII: OSD78555ZM) (BROMIDE ION - UNII:952902IX06)	POTASSIUM BROMIDE	4 [hp_X]  in 1 g
POTASSIUM CARBONATE (UNII: BQN1B9B9HA) (CARBONATE ION - UNII:7UJQ5OPE7D)	POTASSIUM CARBONATE	4 [hp_X]  in 1 g
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479)	LYCOPODIUM CLAVATUM SPORE	4 [hp_X]  in 1 g
SCUTELLARIA LATERIFLORA (UNII: 7BP4DH5PDC) (SCUTELLARIA LATERIFLORA - UNII:7BP4DH5PDC)	SCUTELLARIA LATERIFLORA	4 [hp_X]  in 1 g
TARAXACUM OFFICINALE (UNII: 39981FM375) (TARAXACUM OFFICINALE - UNII:39981FM375)	TARAXACUM OFFICINALE	4 [hp_X]  in 1 g
VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW)	VALERIAN	8 [hp_X]  in 1 g
VERATRUM ALBUM ROOT (UNII: QNS6W5US1Z) (VERATRUM ALBUM ROOT - UNII:QNS6W5US1Z)	VERATRUM ALBUM ROOT	8 [hp_X]  in 1 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58368-002-02	56.7 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	02/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		02/01/2017

Labeler - BioLyte Laboratories, LLC (015560564)

Establishment
Name	Address	ID/FEI	Business Operations
BioLyte Laboratories, LLC		015560564	manufacture(58368-002) , pack(58368-002) , label(58368-002)