Label: CAPSAICIN HEAT PATCHES PAIN RELIEF- 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 August 5, 2022

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  • Active Ingredients

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

  • Purpose

    Topical Analgesic

  • Uses

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

    • Arthiritis
    • Minor backache
    • Strains
    • Sprains
    • Bruises
  • Warnings

    For External Use Only

    Allergy alert

    If you are allergic or suspect you are allergic to the ingredients of this product, including chill peppers, consult with your physician before use.

    Do Not Use:

    • On wounds or damaged skin
    • with pain rubs, medicated lotions, creams, or ointments
    • with heating pads

    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 a manner that always keeps products 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 ingest this patch.

    Stop Use and ask a doctor if:

    • Skin reactions such as redness, itching, rash, excessive irritation, burning sensation, swelling or blistering occur
    • Conditions worsens
    • Symptoms persist more than 7 days
    • Symptoms clear, and reoccur within a few days

    If pregnant or breast-feeding

    Ask a health professional before use

    Keep Out of Reach of Children

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

  • Inactive Ingredients:

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

  • Directions:

    Adults and Children 12 Years of Age and over:

    • Clean and dry affected area
    • Remove patch from film
    • Apply to affected area not more than 3 to 4 times daily
    • use one patch for up to 8 hours
    • Discard after single use
    • Children under 12 years of age: consult a physician
  • Other Information

    • Avoid storage in direct sunlight
    • Protect patch from excessive moisture
  • Inactive Ingredients

    hydrogenated C6-20 polyolefin, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, petroleum, styrene/isoprene copolymer

  • QUESTIONS

    866-326-1313 Monday - Friday 8:30 am -4:30 pm CST

  • LABEL

    label

  • INGREDIENTS AND APPEARANCE
    CAPSAICIN HEAT PATCHES PAIN RELIEF 
    capsaicin patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-4210
    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
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    LIQUID PETROLEUM (UNII: 6ZAE7X688J)  
    STYRENE/ISOPRENE/STYRENE BLOCK COPOLYMER (UNII: K7S96QM8DV)  
    HYDROGENATED C6-20 POLYOLEFIN (100 CST) (UNII: 39EYQ1W9RB)  
    Product Characteristics
    Color    Score    
    ShapeRECTANGLESize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-4210-33 in 1 BOX08/01/2022
    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 finalpart34808/01/2022
    Labeler - Rite Aid (014578892)
    Establishment
    NameAddressID/FEIBusiness Operations
    Foshan Aqua Gel Biotech Co.,Ltd.529128763manufacture(11822-4210)
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