Label: NEORELIEF FOR MUSCLE CRAMPLING AND RESTLESSNESS- topical gel for muscle cramping and restlessness gel
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Contains inactivated NDC Code(s)
NDC Code(s): 58368-002-02 - Packager: BioLyte Laboratories, LLC
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated April 27, 2018
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
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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.
- Purpose
- Uses
- Warnings
- Warnings
- Warnings
- Warnings
- Warnings
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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
- Inactive Ingredients
- Questions or comments?
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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
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INGREDIENTS AND APPEARANCE
NEORELIEF FOR MUSCLE CRAMPLING AND RESTLESSNESS
topical gel for muscle cramping and restlessness gelProduct 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)