YUNNAN BAIYAO ARTHRITIS PAIN RELIEF (CAMPHOR, CAPSAICIN, METHYL SALICYLATE) PLASTER [YUNNAN BAIYAO GROUP CO., LTD.]

YUNNAN BAIYAO ARTHRITIS PAIN RELIEF (CAMPHOR, CAPSAICIN, METHYL SALICYLATE) PLASTER [YUNNAN BAIYAO GROUP CO., LTD.]
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NDC 61658-001-01
Set ID 03a66422-3586-4af9-a9b0-aaebda14b10d
Category HUMAN OTC DRUG LABEL
Packager YUNNAN BAIYAO GROUP CO., LTD.
Generic Name
Product Class
Product Number
Application Number PART348
  • 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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