Label: NUFABRX ARM SLEEVE- capsaicin cloth

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 25, 2024

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  • Active Ingredient

    Synthetic Capsaicin 0.20%

  • 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

    • Allergy Alert: if you are allergic to any ingredients of this product or chili peppers contact a doctor before use
    • On wounds or to damaged skin
    • With, or at same time as, other 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, or sunbathing
    • Use only as directed.
    • Avoid contact with eyes and mucous membranes or rashes.
    • Wash hands after putting product on body and before touching your face or eyes.

    Stop use and ask a 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 breastfeeding 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 product and put on body
    • Maximum use of 8 hours per day
    • Do not wear more than 4 days per week without doctor consent
    • Wash separately for best results
  • Other Information

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

  • Inactive Ingredients

    Acrylate Copolymer

  • Principal Display Panel

    Entire Label

  • INGREDIENTS AND APPEARANCE
    NUFABRX ARM SLEEVE 
    capsaicin cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72490-013
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72490-013-101 g in 1 BOX; Type 0: Not a Combination Product05/22/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01705/22/2020
    Labeler - Nufabrx LLC (119110776)
    Registrant - Biotech Research Group (099152813)