Label: HEALTHWISE CAPSAICIN HEAT PATCH- capsaicin patch

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

Drug Label Information

Updated April 1, 2024

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

  • For External Use Only

    • Allergy alert: if you are allergic or suspect you are allergic to the ingredients listed below, including chili perppers.. consults with your physician before use.
  • Uses

    Temporary relief of minor pain of muscles and joints associated with:

    • Arthiritis
    • Minor backache
    • Strains
    • Sprains
    • Bruises
  • Purpose

    Temporary relief of minor pain associated with: arthritis, minor backache, muscle strains,
    muschle sprains, bruises

  • Active Ingredients

    Capsaicin: 0.025%...........................Topical Analgesic

  • Inactive Ingredients:

    Hydrogenated Poly, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Petroleum, Styrene / Isoprene Copolymer

  • Directions for Use:

    Adults and Childrens 12 Years of Age or Over

    • Clean and dry affected area; free of lotions, ointments and creams
    • Carefully remove backing starting at a corner. Apply sticky side of patch to affected area
    • Do not use more than one patch in an 8-hour period. Repeat as necessary. Maximum 3 patches per day
    • Discard after signle use

    Children under 12 years of age:

    • Consult a physician
  • Keep Out of Reach of Children

    if swallowed, contact a poison control center (1-800-222-1222) right away.

  • Other Information

    • avoid storage in direct sunlight
    • Protect patch from excessive moisture
  • Do Not Use:

    • On wounds or damaged skin
    • with pain rubs, medicated lotions, creams or ointments
    • with a heating pad.
  • When Using this product

    ■ use only as directed

    ■ avoid contact with eyes, mucous membranes or rashes

    ■ do not bandage tightly

    ■ discontinue use at least 1 hour before a bath or shower

    ■ do not use immediately after a bath or shower

    ■ do not microwave

    ■ dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.


  • Stop Use and ask a doctor:

    Stop use and ask a doctor if

    ■ skin reactions such as redness, itching, rash, excessive irritation, burning sensation, swelling or blistering occur

    ■ condition worsens

    ■symptoms persist more than 7 days

    ■symptoms clear and reoccur within a few days.


  • QUESTIONS

    call 1-866-326-1313

  • If pregnant or breast-feeding

    ask a health professional before use.

  • LABEL

    label

  • INGREDIENTS AND APPEARANCE
    HEALTHWISE CAPSAICIN HEAT PATCH 
    capsaicin patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71101-030
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.025 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    LIQUID PETROLEUM (UNII: 6ZAE7X688J)  
    STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)  
    Product Characteristics
    Color    Score    
    ShapeRECTANGLESize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71101-030-2020 in 1 BOX04/01/2024
    19 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01704/01/2024
    Labeler - Veridian Healthcare (830437997)
    Establishment
    NameAddressID/FEIBusiness Operations
    Foshan Aqua Gel Biotech Co.,Ltd.529128763manufacture(71101-030)