Label: CAPSICUM PATCH- camphor,capsicum extract as capsaicin, menthol patch

  • NDC Code(s): 81484-701-01, 81484-701-02
  • Packager: Anhui Miao De Tang Pharmaceutical Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 14, 2023

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

  • SPL UNCLASSIFIED SECTION

    CAPSICUM PATCH

  • ACTIVE INGREDIENT

    Camphor 9.6%

    Capsicum extract as Capsaicin 0.25%

    Menthol 7.8%

  • PURPOSE

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

    · arthritis

    · simple backache

    · strains

    · bruises

  • INDICATIONS & USAGE

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

    arthritis

    simple backache

    strains

    bruises

    TOPICAL ANALGESIC

  • WARNINGS

    For external use only

    When using this product

    avoid contact with the eyes
    do not apply to wounds or damaged skin
    do not bandage tightly
    use only as directed
    avoid contact with the eyes, mucous membranes, or rashes

  • DO NOT 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

  • WHEN USING

    lf 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 right away.

  • 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

    Keep out of reach of children.

  • STORAGE AND HANDLING

    avoid storing products in direct sunlight.

    protect products from excessive moisture.

  • INACTIVE INGREDIENT

    lanolin, lithopone, paraffin, resin, rosin, vaseline

  • DOSAGE & ADMINISTRATION

    Adults and children 12 years of age and older:
    clean and dry the affected area.

    remove the patch from the film.

    apply to affected area not more than 3 to 4 times daily for 7 days

    remove patch from the skin after at most 8-hour application

    Children under 12 years of age:

    consult a doctor.

  • PRINCIPAL DISPLAY PANEL

    Package Drawing

  • INGREDIENTS AND APPEARANCE
    CAPSICUM PATCH 
    camphor,capsicum extract as capsaicin, menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81484-701
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL7.8 g
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.25 g
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)9.6 g
    Inactive Ingredients
    Ingredient NameStrength
    TERPENE RESIN (UNII: GR35AH6YDN)  
    ROSIN (UNII: 88S87KL877)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    LANOLIN (UNII: 7EV65EAW6H)  
    LITHOPONE (UNII: BU2HVV8RW9)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81484-701-0220 in 1 BOX06/21/2023
    1NDC:81484-701-011 in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01706/21/2023
    Labeler - Anhui Miao De Tang Pharmaceutical Co., Ltd. (405744102)
    Establishment
    NameAddressID/FEIBusiness Operations
    Anhui Miao De Tang Pharmaceutical Co., Ltd.405744102manufacture(81484-701)