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Neurodexx - Prescription Drug Labeling

Product NDC Code 81649-030
Drug Name

Neurodexx

Type Brand
Active Ingredients
Methyl salicylate 18 g/60ml
Menthol 6 g/60ml
Capsaicin .015 g/60ml
Route TOPICAL
Dosage Form LOTION
RxCUI drug identifier 1116967
Application Number part348
Labeler Name Rely Wellness
Packages
Package NDC Code Description
81649-030-04 120 ml in 1 bottle (81649-030-04)
81649-030-25 .25 ml in 1 packet (81649-030-25)

Active ingredient

A list of the active, medicinal ingredients in the drug product.
ACTIVE INGREDIENTS Methyl Salicylate 30% Menthol 10% Capsaicin 0.025%

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
Directions: Use only as directed. Shake before each use. Prior to first use rub small amount to check for sensitivity. Gently rub over painful areas. Dry before contact with clothes or bedding to avoid staining. Wash hands after use. Do not use more than 4 times daily or if pregnant or nursing. If swallowed, call poison control. If placed into eyes, rinse with cold water and call a doctor.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients: Water, Benzocaine, Glyceryl Stearate, PEG 100 Stearate, Stearic Acid, Cetyl Alcohol, Propylene Glycol, Dimethyl Sulfoxide, Triethanolamine, Poloxamer 407, Aloe Barbadensis Gel, Borage Oil, Ammonium Acryloyldimethyltaurate/VP Copolymer, Zingiber Officinale Root Extract, Methylparaben, Propylparaben, Soy Lecithin, DMDM Hydantoin, Sodium Stearoyl Glutamate

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Uses: For temporary relief of mild pain due to muscular strain, arthritis, and simple back pain. Does not cure any disease.

Purpose

Information about the drug product’s indications for use.
Purpose Topical Analgesic

Spl product data elements

Usually a list of ingredients in a drug product.
Neurodexx Pain Relief WATER BENZOCAINE GLYCERYL MONOSTEARATE PEG-100 STEARATE STEARIC ACID PROPYLENE GLYCOL CETYL ALCOHOL DIMETHYL SULFOXIDE POLOXAMER 407 ALOE VERA LEAF BORAGE SEED OIL AMMONIO METHACRYLATE COPOLYMER TYPE A GINGER LECITHIN, SOYBEAN METHYLPARABEN PROPYLPARABEN DMDM HYDANTOIN SODIUM STEAROYL GLUTAMATE TROLAMINE METHYL SALICYLATE SALICYLIC ACID MENTHOL MENTHOL CAPSAICIN CAPSAICIN

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
Neurodexx™ Pain Relief Hot Deep Penetrating MAXIMUM STRENGTH Topical Pain Relief Lotion Provides Fast Temporary Relief from: Arthritis pain Muscular & Rheumetric pain Joint pain & stifness Doctor Recommended Doctor Formulated Dermatologically Tested Hypoallergenic 120 ml (4 fl oz) NDC 81649-030-04 0.25gm (0.25 ml) NDC 81649-030-25 Bottle Sample

Spl unclassified section

Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
Manufactured for: Rely Wellness 5777 W. Century Blvd, #1100 Unit #371, Los Angeles, CA 90045

Do not use

Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.
Do Not Use: On cuts or infected skin, on children less than 12 years old, in large amounts, especially over raw or blistered skin, if allergic to any ingredients, PABA, aspirin products, or sulfa. Store below 90°F/32°C.

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep Out Of Reach Of Children And Pets: If swallowed get medical help or contact a Poison Control Center right away.

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
Stop Use and Ask a Physician: For severe undiagnosed pain. If pain worsens or persist for more than 7 days. If pain clears up and then recurs in a few days. If itching or rash occurs.

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
Warnings: For external use only. Do not use in eyes, mouth or mucous membranes, or genitals. Do not allow treated skin to contact infants or pets. Do not tightly bandage. Do not use with heating pad. Do not use with other topical pain products. May stain furniture, clothing or bedding.

Disclaimer: Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API