Label: 2-COUNT HEAT PATCHES- 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 November 21, 2018

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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.

  • 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, contacr 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

  • LABEL

    Manufactured For:

    Veridian Healthcare, LLC

    1175 Lakeside Drive

    Gurnee, IL 60031 USA

    Made in China

    Capsaicin Heat Path

  • INGREDIENTS AND APPEARANCE
    2-COUNT HEAT PATCHES 
    capsaicin patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71101-904
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.25 g  in 1 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:71101-904-022 in 1 BOX11/21/2018
    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 finalpart34811/21/2018
    Labeler - Veridian Healthcare (830437997)
    Establishment
    NameAddressID/FEIBusiness Operations
    Foshan Aqua Gel Biotech Co.,Ltd.529128763manufacture(71101-904)
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