Label: ARTHRITIS PAIN RELIEF- camphor, capsaicin, methyl salicylate patch

  • NDC Code(s): 61658-002-01
  • Packager: YUNNAN BAIYAO GROUP CO., LTD.
  • 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 October 3, 2023

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  • ACTIVE INGREDIENT

    Active ingredients
    Camphor 11%
    Capsaicin 0.25%
    Methyl salicylate 14.24%

  • PURPOSE

    Purpose
    External analgesic
    External analgesic
    External analgesic

  • INDICATIONS & USAGE

    Uses For the temporary relief of minor aches and pains of muscles and joints due to:
    simple backache
    arthritis
    strains
    bruises
    sprains

  • WARNINGS

    Warnings

    For external use only

    Allergy alert: This product contains natural rubber latex which may cause allergic reactions

  • DO NOT USE

    Do not use
    on irritated or damaged skin
    on wounds
    otherwise than as directed

  • WHEN USING

    When using this product
    avoid contact with the eyes or mucous membranes
    do not bandage tightly

  • STOP USE

    Stop use and ask a doctor ifcondition worsens
    symptoms persist for more than 7 days
    symptoms clear up and occur again within a few days
    excessive irritation of the skin develops
    nausea, vomiting, abdominal discomfort, diarrhea, or skin rash occurs
    when using for pain of arthritis:
         pain persists for more than 10 days
         redness is present
         in conditions affecting children under 12 years of age

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children to avoid accidental poisoning. If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions
    adults and children 3 years of age and older: remove the attached film from the plaster. Apply to affected area not more than 3 to 4 times daily
    children under 3 years of age: consult your physician
    refer to the above warnings; use otherwise than as directed may be dangerous

  • STORAGE AND HANDLING

    Other information
    keep tightly closed
    store at 15 to 30C (59 to 86F)

  • INACTIVE INGREDIENT

    Inactive ingredients Peppermint oil, petrolatum, lanolin, rosin, and zinc oxide, on a natural latex rubber pad.

  • QUESTIONS

    Questions or comments? (888) 221-3496 M-F 9 am to 5 pm
    you may also report serious side effects to this phone number

  • PRINCIPAL DISPLAY PANEL

    ARTHRITIS PAIN RELIEF PATCH

    External Analgesic

    NDC 61658-002-01

    Camphor 11%, Capsaicin 0.25%, Methyl Salicylate 14.24%

    6 Patches
    Each Patch 7 x 10 cm (2.76 x 3.94 in)

    IMAGE OF CARTON

  • INGREDIENTS AND APPEARANCE
    ARTHRITIS PAIN RELIEF 
    camphor, capsaicin, methyl salicylate patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61658-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)128.04 mg
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN2.88 mg
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE168.03 mg
    Inactive Ingredients
    Ingredient NameStrength
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    LANOLIN (UNII: 7EV65EAW6H)  
    ROSIN (UNII: 88S87KL877)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61658-002-011 in 1 BOX08/07/2023
    16 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/07/2023
    Labeler - YUNNAN BAIYAO GROUP CO., LTD. (654223122)
    Establishment
    NameAddressID/FEIBusiness Operations
    YUNNAN BAIYAO GROUP CO., LTD.654223122manufacture(61658-002)
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