NEORELIEF FOR MUSCLE CRAMPLING AND RESTLESSNESS- topical gel for muscle cramping and restlessness gel 
BioLyte Laboratories, LLC

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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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.

NeoRelief Muscle Cramp

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) Muscle Cramp and Restlessness

NEORELIEF FOR MUSCLE CRAMPLING AND RESTLESSNESS 
topical gel for muscle cramping and restlessness gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58368-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU) CAUSTICUM4 [hp_X]  in 1 g
JATROPHA CURCAS SEED (UNII: J0F5GM8LA8) (JATROPHA CURCAS SEED - UNII:J0F5GM8LA8) JATROPHA CURCAS SEED8 [hp_X]  in 1 g
FRANGULA CALIFORNICA BARK (UNII: 1LZ13MQR0S) (FRANGULA CALIFORNICA BARK - UNII:1LZ13MQR0S) FRANGULA CALIFORNICA BARK4 [hp_X]  in 1 g
RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S) RUTA GRAVEOLENS FLOWERING TOP4 [hp_X]  in 1 g
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA4 [hp_X]  in 1 g
ATROPA BELLADONNA ROOT (UNII: 6MW97Q6E8M) (ATROPA BELLADONNA ROOT - UNII:6MW97Q6E8M) ATROPA BELLADONNA ROOT4 [hp_X]  in 1 g
BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9) BLACK COHOSH4 [hp_X]  in 1 g
ARTEMISIA CINA PRE-FLOWERING TOP (UNII: 28M1820ACT) (ARTEMISIA CINA PRE-FLOWERING TOP - UNII:28M1820ACT) ARTEMISIA CINA PRE-FLOWERING TOP8 [hp_X]  in 1 g
PSEUDOGNAPHALIUM OBTUSIFOLIUM (UNII: 36XQ854NWW) (PSEUDOGNAPHALIUM OBTUSIFOLIUM - UNII:36XQ854NWW) PSEUDOGNAPHALIUM OBTUSIFOLIUM4 [hp_X]  in 1 g
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM4 [hp_X]  in 1 g
STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED4 [hp_X]  in 1 g
POTASSIUM BROMIDE (UNII: OSD78555ZM) (BROMIDE ION - UNII:952902IX06) POTASSIUM BROMIDE4 [hp_X]  in 1 g
POTASSIUM CARBONATE (UNII: BQN1B9B9HA) (CARBONATE ION - UNII:7UJQ5OPE7D) POTASSIUM CARBONATE4 [hp_X]  in 1 g
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE4 [hp_X]  in 1 g
SCUTELLARIA LATERIFLORA (UNII: 7BP4DH5PDC) (SCUTELLARIA LATERIFLORA - UNII:7BP4DH5PDC) SCUTELLARIA LATERIFLORA4 [hp_X]  in 1 g
TARAXACUM OFFICINALE (UNII: 39981FM375) (TARAXACUM OFFICINALE - UNII:39981FM375) TARAXACUM OFFICINALE4 [hp_X]  in 1 g
VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN8 [hp_X]  in 1 g
VERATRUM ALBUM ROOT (UNII: QNS6W5US1Z) (VERATRUM ALBUM ROOT - UNII:QNS6W5US1Z) VERATRUM ALBUM ROOT8 [hp_X]  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58368-002-0256.7 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product02/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic02/01/2017
Labeler - BioLyte Laboratories, LLC (015560564)
Establishment
NameAddressID/FEIBusiness Operations
BioLyte Laboratories, LLC015560564manufacture(58368-002) , pack(58368-002) , label(58368-002)

Revised: 4/2018
Document Id: 71c186a1-8282-2482-e053-2995a90acc1f
Set id: 46da3f0e-9dd1-6495-e054-00144ff8d46c
Version: 6
Effective Time: 20180427
 
BioLyte Laboratories, LLC