Label: NUFABRX LOWER LEG SLEEVE- capsaicin cloth

  • NDC Code(s): 72490-018-10
  • Packager: Textile-Based Delivery Inc.
  • 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 January 14, 2021

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

  • Active Ingredient

    Capsaicin (Nonivamide) 0.18%

  • Purpose

    Topical Analgesic

  • Uses

    For the temporary relief of minor aches and pains of muscles and joints associated with: Simple backache, arthritis, strains, bruises and sprains.

  • Warnings

    For external use only

    Do not use

    • If you are allergic to any ingredents of this product o chili peppers, contact a doctor before use (allergy alert)
    • On wounds or damages skin
    • With, or at the same time as, other external anlgesic products
    • With a heating pad

    When using this product

    • You may experience a burning sensation which is normal and related to the way the product works (with regular use, this sensation generally diminishes)
    • Do not use immediately before or after activities such as swimming, showering, sunbathing or intense exercise
    • Use only as directed
    • Avoid contact with eyes and mucous membranes or rashes

    Stop use and ask doctor if

    • Condition worsens, symptoms persist more than 7 days or clear up and occur again within a few days
    • Rash, itching or excessive skin irriation develops

    If pregnant or beastfeeding

    Consult a healthcare professional before use

    Keep out of reach of children

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

  • Directions

    • Clean and dry affected area
    • Remove sleeve from packagin and place on lower leg
    • Maximum use of 10 hours per day
    • Wash separately from other clothing
    • Do not wear more than 6 days straight without doctor consent
  • Other information

    Avoid storing product in direct sunlight. Protect product from excessive moisture.

  • Inactive ingredients

    Acrylate copolymer

  • Package Label

    Entire Label

  • INGREDIENTS AND APPEARANCE
    NUFABRX LOWER LEG SLEEVE 
    capsaicin cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72490-018
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.18 
    Inactive Ingredients
    Ingredient NameStrength
    BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72490-018-101 in 1 BOX; Type 0: Not a Combination Product01/14/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/14/2021
    Labeler - Textile-Based Delivery Inc. (079309716)