Label: NEURODEXX- pain relief lotion

  • NDC Code(s): 81649-030-04, 81649-030-25
  • Packager: Rely Wellness
  • Category: HUMAN OTC DRUG LABEL

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.

Drug Label Information

Updated January 16, 2023

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  • 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

  • SPL UNCLASSIFIED SECTION

    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

    0.25gm (0.25 ml)

    NDC 81649-030-25

    Sample

  • INGREDIENTS AND APPEARANCE
    NEURODEXX 
    pain relief lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81649-030
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE18 g  in 60 mL
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL6 g  in 60 mL
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.015 g  in 60 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BENZOCAINE (UNII: U3RSY48JW5)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIMETHYL SULFOXIDE (UNII: YOW8V9698H)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BORAGE SEED OIL (UNII: F8XAG1755S)  
    AMMONIO METHACRYLATE COPOLYMER TYPE A (UNII: 8GQS4E66YY)  
    GINGER (UNII: C5529G5JPQ)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81649-030-250.25 mL in 1 PACKET; Type 0: Not a Combination Product05/01/2021
    2NDC:81649-030-04120 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/01/2021
    Labeler - Rely Wellness (117943776)
    Establishment
    NameAddressID/FEIBusiness Operations
    Westwood Laboratories Inc.832280635manufacture(81649-030)
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