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

  • 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 July 9, 2018

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

  • 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

    Capsaicin 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
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/01/2017
    Labeler - Walgreen Company (008965063)
    Establishment
    NameAddressID/FEIBusiness Operations
    Foshan Aqua Gel Biotech Co.,Ltd.529128763manufacture(0363-9902)