Label: NUFABRX KNEE SLEEVE- capsaicin cloth

  • NDC Code(s): 72490-025-11, 72490-026-11, 72490-027-11
  • Packager: Nufabrx LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 10, 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 DrugM01703/29/2021
    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 DrugM01703/29/2021
    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 DrugM01703/29/2021
    Labeler - Nufabrx LLC (119110776)
    Registrant - Biotech Research Group (099152813)
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