Label: DENDRACIN NEURODENDRAXCIN- methyl salicylate, menthol and capsaicin lotion

  • 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 21, 2021

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • 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.

  • Warnings:

    For external use only. Do not use in eyes, mouth, on mucous membranes, or genitals. Do not tightly bandage. Do not use with heating pad. Do not use with other topical pain products.

  • Keep away from children.

  • 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, zingiber officinale root extract, methylparaben, propylparaben, soya lecithin, DMDM hydantoin, sodium stearoyl glutamate.

  • SPL UNCLASSIFIED SECTION

    Manufactured for Physicians' Science and Nature, Inc.

    220 Newport Center Drive 11-634, Newport Beach, CA 92660

    Made in the USA

    Patent Pending

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    DENDRACIN NEURODENDRAXCIN 
    methyl salicylate, menthol and capsaicin lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35356-642(NDC:27495-014)
    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)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIMETHYL SULFOXIDE (UNII: YOW8V9698H)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BORAGE 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:35356-642-04120 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package11/14/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/14/2011
    Labeler - Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC (831276758)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC831276758relabel(35356-642)