Label: CAPSAICIN HEAT- capsaicin patch

  • NDC Code(s): 52000-040-40, 52000-040-41
  • Packager: Universal Distribution Center LLC
  • Category: HUMAN OTC DRUG LABEL

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 March 7, 2019

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  • ACTIVE INGREDIENT

    Active Ingredient

    Capsicum Extract Capsaicin 0.025%

  • PURPOSE

    Purpose

    Topical Analgesic

  • INDICATIONS & USAGE

    Uses

    For temporary relief of minor aches and pains of muscles & joints associated with:

    • Simple Backache
    • Arthritis
    • Strains
    • Bruises
    • Sprains
  • WARNINGS

    Warnings

    External use only.

  • DO NOT USE

    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

    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

    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 a few days
  • KEEP OUT OF REACH OF CHILDREN

    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.

  • DOSAGE & ADMINISTRATION

    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.

  • SPL UNCLASSIFIED SECTION

    Other information

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

    Inactive Ingredients

    lanolin, methyl salicylate, natural latex rubber, peppermint oil, petrolatum, rosin, zinc oxide

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL

    Capsaicin Heat Patch

    label

  • 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
    LANOLIN (UNII: 7EV65EAW6H)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    ROSIN (UNII: 88S87KL877)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    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 not finalpart34803/07/2019
    Labeler - Universal Distribution Center LLC (019180459)
    Registrant - Universal Distribution Center LLC (019180459)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Dingtai Pharmaceutical Co., Ltd420598724manufacture(52000-040)
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