Label: CAPSAICIN HEAT PATCHES BACK AND LARGE AREAS- capsaicin patch

  • NDC Code(s): 0363-9902-02, 0363-9902-03
  • Packager: Walgreen Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 17, 2024

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  • For External Use Only

    • Discontinue use at least one hour prior to bath / shower / swimming; do not use immediatelty after bath / shower / swimming.
    • 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 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:

    For Use on Adults and Childrens 12 Years of Age or Older

    • Clean and dru affected area; ensure area is fully dry before application
    • Remove patch from film
    • Apply to treatement site
    • Patch may be trimmerd to best fit treatment site; trim patch before removing film
    • Wash hands after application
    • Discard after signle use

    Caution:

    • Take care when using on elderly ot incapacited persons
    • Do not use more than 8 hours
    • Do not use the Capsaicin Heat Patch more than 3-4 times daily
    • Do not exceed 7 days of continue use
  • Keep Out of Reach of Children

    if swallowed, contact a poison control center immediately.

  • Storage and Care:

    • One time use only; do not attempt to reuse the product
    • avoid storage in direct sunlight
    • Protect patch from excessive moisture
  • Do Not Use:

    • On areas with sensitive skin, open wounds or previous burns
    • with pain rubs, medicated lotions, creams or oinments
    • with other forms of heat theraphy, including heating pads, or multiples of this treatment on a single treatement site
  • Use Only as Directed:

    • Follow the below directions for use.
    • Avoid contact with eyes, mucus membrances or skin rashes.

  • Stop Use immediately and Seek Medical Attention if:

    • Rash, itching or excessive skin irritation develops
    • Conditions worsens
    • Symptons persist more than 7 days
    • Symptoms clear, and reoccur within a few days
  • QUESTIONS

    TOLL-FREE

    Customer Care Help Line
    866-326-1313
    Mon–Fri 8:30 am–4:30 pm CST

    DIST. BY
    WALGREEN CO.
    200 WILMOT RD.
    DEERFIELD, IL 60015
    www.walgreens.com


    Made in China

  • LABEL

    labelCapsaicin Heat Path

  • INGREDIENTS AND APPEARANCE
    CAPSAICIN HEAT PATCHES BACK AND LARGE AREAS 
    capsaicin patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-9902
    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:0363-9902-033 in 1 BOX07/01/2018
    19 g in 1 PATCH; Type 0: Not a Combination Product
    2NDC:0363-9902-022 in 1 BOX05/01/2023
    29 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01706/01/2017
    Labeler - Walgreen Company (008965063)
    Establishment
    NameAddressID/FEIBusiness Operations
    Foshan Aqua Gel Biotech Co.,Ltd.529128763manufacture(0363-9902)
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