Label: NUFABRX KNEE SLEEVE- capsaicin cloth

  • NDC Code(s): 72490-025-11, 72490-026-11, 72490-027-11
  • Packager: Texdel-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 7, 2023

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  • 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 ingredients of this product or chili peppers, contact a doctor before use (allergy alert)
    • On wounds or damaged skin
    • With, or at the same time as, other external analgesic 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 irritation develops

    If pregnant or breast feeding

    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 packaging and place on knee
    • 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

  • Principal Display and Drug Facts

    Front LabelBack Label 72490-025Back Label 72490-026Back Label 72490-027

  • INGREDIENTS AND APPEARANCE
    NUFABRX KNEE SLEEVE 
    capsaicin cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72490-026
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.18 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)  
    Product Characteristics
    Colorblack (Size M/L) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72490-026-111 g in 1 POUCH; Type 0: Not a Combination Product03/29/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/29/2021
    NUFABRX KNEE SLEEVE 
    capsaicin cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72490-027
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.18 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)  
    Product Characteristics
    Colorblack (Size XL/XXL) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72490-027-111 g in 1 POUCH; Type 0: Not a Combination Product03/29/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/29/2021
    NUFABRX KNEE SLEEVE 
    capsaicin cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72490-025
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.18 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)  
    Product Characteristics
    Colorblack (Size XS/S) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72490-025-111 g in 1 POUCH; Type 0: Not a Combination Product03/29/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/29/2021
    Labeler - Texdel-Based Delivery, Inc. (079309716)
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