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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 April 15, 2021

If you are a consumer or patient 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 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.

  • Keep away from children and pets.

  • 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 Physician’s Science and Nature Inc.
    220 Newport Center Drive 11-634, Newport Beach, CA 92660

    Made in the USA
    Patent Pending

    Relabeled by Preferred Pharmaceuticals, Inc.

     
    60ml NDC 68788-7696-06
     
    120ml NDC 68788-7696-01
  • Principal Display Panel

    Physician's Science and Nature Inc.

    DENDRACIN
    Neurodendraxcin®

    Professional Formula
    Dermatologically Tested
    Hypoallergenic

    Topical Pain Relief Lotion
    Deep Penetrating Action


    NDC 68788-7696

    Relabeled by Preferred Pharmaceuticals, Inc.

    Dendracin Topical Pain Relief Lotion
  • INGREDIENTS AND APPEARANCE
    DENDRACIN NEURODENDRAXCIN 
    methyl salicylate, menthol and capsaicin lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-7696(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, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM6 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:68788-7696-660 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/2020
    2NDC:68788-7696-1120 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/01/2020
    Labeler - Preferred Pharmaceuticals, Inc. (791119022)
    Registrant - Preferred Pharmaceuticals, Inc. (791119022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Preferred Pharmaceuticals, Inc.791119022RELABEL(68788-7696)