Label: NEURITERX- capsaicin 0.05% cream

  • NDC Code(s): 57483-221-01
  • Packager: Innovus Pharmaceuticals, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 8, 2023

If you are a consumer or patient please visit this version.

  • Active Ingredient

    Capsaicin 0.05%

  • Purpose

    Topical Analgesic

  • Uses

    For the temporary relief of minor aches and pains of muscles and joints associated with:
    • simple backache

    • arthritis

    • strains

    • bruises

    • sprains

  • Warnings

    For external use only

  • When using this product

    • use only as directed
    • do not bandage tightly
    • do not use with heating pad
    • avoid contact with eyes and mucous membranes
    • do not apply to wounds, damaged, broken or irritated skin
    • a transient burning sensation may occur upon application but generally disappears in several days
    • if severe burning sensation occurs, discontinue use immediately
    • do not expose the area treated with product to heat or direct sunlight

  • Stop use and ask a doctor if

    • Condition worsens

    • Redness is present

    • Irritation develops 

    • Symptoms persist for more than 7 days or symptoms clear up and occur again within a few days

  • Keep out of reach of children

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

  • Directions

    Adults and children over 18 years:

    • Apply to affected area
    • Massage into painful area until thoroughly absorbed
    • Repeat as necessary, but no more than 3 to 4 times daily


    Children 18 years or younger: ask a doctor

  • Other Information

    Store at 20° - 25°C (68° - 77°F)

    Do not use if inner container seal is damaged or missing.

  • Inactive Ingredients

    Almond Oil, Benzyl Alcohol, Benzyl Benzoate, Butylated Hydroxytoluene, Carbomer Copolymer Type B, Cinnamon Bark Oil, Coriander Oil, Edetate Disodium, Isopropyl Alcohol, L-Arginine HCl, L-Citrulline , Polyoxl 40 Hydrogenated Castor Oil, Propylene Glycol, Sorbitol,Trolamine, Water

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    NEURITERX 
    capsaicin 0.05% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57483-221
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN.05 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALMOND OIL (UNII: 66YXD4DKO9)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)  
    CINNAMON BARK OIL (UNII: XE54U569EC)  
    CORIANDER OIL (UNII: 7626GC95E5)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    ARGININE HYDROCHLORIDE (UNII: F7LTH1E20Y)  
    CITRULLINE (UNII: 29VT07BGDA)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITOL (UNII: 506T60A25R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57483-221-011 in 1 CARTON02/02/2021
    156.7 g in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02/02/2021
    Labeler - Innovus Pharmaceuticals, Inc. (962507187)
    Registrant - Innovus Pharmaceuticals, Inc. (962507187)
    Establishment
    NameAddressID/FEIBusiness Operations
    Topical Pharmaceuticals Inc.831530683manufacture(57483-221)