Label: CAPSAICIN HEAT- capsaicin patch

  • NDC Code(s): 52000-040-40, 52000-040-41
  • Packager: Universal Distribution Center LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 5, 2024

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

  • Drug Facts

  • Active Ingredient

    Capsicum Extract Capsaicin 0.025%

  • Purpose

    Topical Analgesic

  • Uses

    For temporary relief of minor aches and pains of muscles & joints associated with:
    • Simple Backache  • Arthritis  • Strains  • Bruises  • Sprains

  • WARNINGS:

    EXTERNAL USE ONLY

    DO NOT USE
    • on wounds or damaged skin
    • with a heating pad
    • with or at the same times as other external analgesic
    • if you are allergic to any ingredients of this product

    When using this product
    • do not use otherwise than as directed.
    • avoid contact with the 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

    STOP USE and ask a doctor if
    • rash, itching or excessive skin irritation develops
    • conditions worsen
    • symptoms persist for more than 7 days
    • symptoms clear up and occur again within few days

    If pregnant or breast-feeding, ask a health professional before use.

    KEEP OUT OF REACH OF CHILDREN.

    If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

  • 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
    • Remove patch from skin after at most 8 hours of application

    Children under 12 years of age: Consult a doctor.

  • Other Information

    • Avoid storing product in direct sunlight
    • Protect product from excessive moisture

  • Inactive Ingredients

    Glycerin, Sodium Polyacrylate, Dihydroxyaluminium Aminoacetate Anhydrous, Edetate Disodium, Kaolin, Propylene Glycol, Polysorbate 80, Carboxymethylcellulose Sodium, Carbomer, Purified Water, POVIDONE K90, Tartaric Acid, DMDM Hydantoin

  • SPL UNCLASSIFIED SECTION

    Compare to the active ingredient in Salonpas® - Hot Capsicum Patch®

    *This product is NOT manufactured or distributed by Hisamitsu®, owner of Salonpas® Hot Capsicum Patch.

    Distributed by:

    Universal Distribution Center

    96 Distribution Boulevard • Edison, NJ 08817

    Made in P.R.C.

  • Packaging

    HEATpatch-rev5

  • INGREDIENTS AND APPEARANCE
    CAPSAICIN HEAT 
    capsaicin patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52000-040
    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
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    KAOLIN (UNII: 24H4NWX5CO)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)  
    WATER (UNII: 059QF0KO0R)  
    POVIDONE K90 (UNII: RDH86HJV5Z)  
    TARTARIC ACID (UNII: W4888I119H)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52000-040-411 in 1 BOX03/07/2019
    1NDC:52000-040-402 in 1 POUCH
    13.28 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01703/07/2019
    Labeler - Universal Distribution Center LLC (019180459)
    Registrant - Universal Distribution Center LLC (019180459)
    Establishment
    NameAddressID/FEIBusiness Operations
    Koolcare Technology Co., Ltd.602479389manufacture(52000-040)