Label: PAIN RELIEF PATCH- camphor, menthol, methyl salicylate patch

  • NDC Code(s): 81484-801-01, 81484-801-02
  • Packager: Anhui Miao De Tang Pharmaceutical Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 14, 2023

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  • SPL UNCLASSIFIED SECTION

    Pain Relief Patch

  • ACTIVE INGREDIENT

    Camphor 3.1%

    Menthol 6.0%

    Methyl Salicylate 10.0%

  • PURPOSE

    For the temporary minor aches and pains of muscles and joints associated with:
    arthritis
    simple backache
    strains
    bruises
    sprains

  • INDICATIONS & USAGE

    For the temporary minor aches and pains of muscles and joints associated with:
    arthritis
    simple backache
    strains
    bruises
    sprains

  • WARNINGS

    For external use only

    if prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

  • DO NOT USE

    on wounds or damaged skin

    with a heating pad

    at the same time as other topical analgesics

    if you are allergic to any ingredients of this product

  • WHEN USING

    use only as directed

    avoid contact with the eyes, mucous membranes, or rashes

    do not bandage tightly

  • STOP USE

    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
    if swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Adults and children 12 years of age and over:

    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

  • STORAGE AND HANDLING

    store in a clean, dry place outside of direct sunlight

    protect from excessive moisture

  • INACTIVE INGREDIENT

    hydrogenated poly

    Pentaerythrityl tetra-di-t-butyl

    hydroxyhydrocinnamate

    petroleum

    styrene/isoprene copolymer

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF PATCH 
    camphor, menthol, methyl salicylate patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81484-801
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)3.1 mg  in 100 
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE10 mg  in 100 
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL6 mg  in 100 
    Inactive Ingredients
    Ingredient NameStrength
    HYDROGENATED POLYISOBUTENE 8 (UNII: 7YR4ZFS62E)  
    NAPHTHA (UNII: O3L624621X)  
    ETHYL P-HYDROXYHYDROCINNAMATE (UNII: 8R568DFF4T)  
    STYRENE (UNII: 44LJ2U959V)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81484-801-0215 in 1 BOX07/26/2023
    1NDC:81484-801-011 in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01707/26/2023
    Labeler - Anhui Miao De Tang Pharmaceutical Co., Ltd. (405744102)
    Registrant - Anhui Miao De Tang Pharmaceutical Co., Ltd. (405744102)
    Establishment
    NameAddressID/FEIBusiness Operations
    Anhui Miao De Tang Pharmaceutical Co., Ltd.405744102manufacture(81484-801)
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