Label: MEDICATED COMPRESSION SOCK- capsaicin cloth

  • 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 December 17, 2019

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  • Active Ingredient

    Synthetic Capsaicin 0.13%

  • 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 damaged skin
    • With, or at 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, 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

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  • INGREDIENTS AND APPEARANCE
    MEDICATED COMPRESSION SOCK 
    capsaicin cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72490-006
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.13 
    Inactive Ingredients
    Ingredient NameStrength
    BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72490-006-012 in 1 POUCH; Type 0: Not a Combination Product07/16/2019
    2NDC:72490-006-022 in 1 POUCH; Type 0: Not a Combination Product07/16/2019
    3NDC:72490-006-032 in 1 POUCH; Type 0: Not a Combination Product07/16/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/16/2019
    Labeler - Textile-Based Delivery, Inc. (079309716)
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