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

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated March 28, 2022

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  • ACTIVE INGREDIENT

    Methyl Salicylate 30%
    Menthol 10%
    Capsaicin 0.025%

  • PURPOSE

    Topical Analgesic

  • 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 OUT OF REACH OF CHILDREN

  • INDICATIONS & USAGE

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

  • STOP USE

    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.

  • 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.

  • INACTIVE INGREDIENT

    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

  • DOSAGE & ADMINISTRATION

    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.

  • PRINCIPAL DISPLAY PANEL

    680

  • INGREDIENTS AND APPEARANCE
    DENDRACIN NEURODENDRAXCIN 
    methyl salicylate, menthol and capsaicin lotion lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61919-680(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
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.015 g  in 60 mL
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL6 g  in 60 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHYL SULFOXIDE (UNII: YOW8V9698H)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    AMMONIO METHACRYLATE COPOLYMER TYPE A (UNII: 8GQS4E66YY)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    GINGER (UNII: C5529G5JPQ)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    BORAGE SEED OIL (UNII: F8XAG1755S)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    BENZOCAINE (UNII: U3RSY48JW5)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61919-680-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product09/14/2021
    2NDC:61919-680-04120 mL in 1 BOTTLE; Type 0: Not a Combination Product09/14/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/14/2021
    Labeler - DirectRx (079254320)
    Registrant - DirectRx (079254320)
    Establishment
    NameAddressID/FEIBusiness Operations
    DirectRx079254320relabel(61919-680)