OTC Medication Information: Neurodexx

NEURODEXX- methyl salicylate, menthol and capsaicin lotion
Rely Wellness

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

ACTIVE INGREDIENTS

Methyl Salicylate 30%
Menthol 10%
Capsaicin 0.025%

Purpose

Topical Analgesic

Uses:

For temporary relief of mild pain due to muscular strain, arthritis, and simple back pain. Does not cure any disease.

Keep Out Of Reach Of Children And Pets:

If swallowed get medical help or contact a Poison Control Center right away.

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.

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.

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.

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.

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

Manufactured for: Rely Wellness
5777 W. Century Blvd, #1100 Unit #371, Los Angeles, CA 90045

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

Bottle
(click image for full-size original)

0.25gm (0.25 ml)

NDC 81649-030-25

Sample
(click image for full-size original)
NEURODEXX
pain relief lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:81649-030
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE 18 g in 60 mL
MENTHOL (MENTHOL) MENTHOL 6 g in 60 mL
CAPSAICIN (CAPSAICIN) CAPSAICIN 0.015 g in 60 mL
Inactive Ingredients
Ingredient Name Strength
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
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:81649-030-25 0.25 mL in 1 PACKET None
2 NDC:81649-030-04 120 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 05/01/2021
Labeler — Rely Wellness (117943776)
Establishment
Name Address ID/FEI Operations
Westwood Laboratories Inc. 832280635 manufacture (81649-030)

Revised: 01/2023 Rely Wellness

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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