Label: YUNNAN BAIYAO ARTHRITIS PAIN RELIEF- camphor, capsaicin, methyl salicylate plaster

  • 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 June 18, 2015

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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 if


    • condition 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 30° C (59° to 86° F)
  • 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

    YUNNAN BAIYAO ARTHRITIS PAIN RELIEF PLASTER
    External Analgesic
    NDC 61658-001-01
    Camphor 11%, Capsaicin 0.25%, Methyl Salicylate 14.24%
    6 Plasters
    Each Plaster 7 x 10 cm (2.76 x 3.94 in)
    IMAGE OF CARTON

  • INGREDIENTS AND APPEARANCE
    YUNNAN BAIYAO ARTHRITIS PAIN RELIEF 
    camphor, capsaicin, methyl salicylate plaster
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61658-001
    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:61658-001-011 in 1 BOX
    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 finalpart34806/18/2015
    Labeler - YUNNAN BAIYAO GROUP CO., LTD. (654223122)
    Establishment
    NameAddressID/FEIBusiness Operations
    YUNNAN BAIYAO GROUP CO., LTD.654223122manufacture(61658-001)
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