Label: TIBETREE PAIN RELIEVEING PLASTER- camphor 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 April 30, 2019

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  • Active ingredients

    Camphor 1%.................……….…….External analgesic

  • ASK DOCTOR

    Do not use otherwise than as directed

  • Keep out of reach of children

    Keep out of reach of children to avoid accidental poisoning

  • If pregnant

    If pregnant, ask a health professional before use

  • Directions

    • Adults and children 12 years of age and older: remove plaster from the protective film, apply to the affected area as directed.
    • Use 1 to 2 plasters every 24 hours for a consecutive five days as a treatment cycle.
    • Apply the plaster to the affected area for 4 to 8 hours.
    • Do not apply to area with excessive hair. Adhesive plaster may hurt skin upon removal.
    • Children under 12 years of age: Do not use or consult a doctor.
  • Other information

    store at room temperature, 20° to 25°C(68° to 77F)

  • Inactive ingredients

    Sichuan pepper pericarp, Lamiophlomis rotate root, Turmeric rhizome, Myricaria paniculata stem, Safflower flower, Oxytropis chiliophylla plant

  • Questions?

    +1-510-780-9118

    For external use only

    For external use only

  • Purpose

    External analgesic

  • Do not use

    • on wounds
    • irritated or damaged skin
    • sensitive skin
  • When using this product

    • avoid contact with the eyes
    • do not use more than 2 plasters a day
    • do not use 1 hour before or after bathing
  • 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
    • redness is present
  • Warnings

    For external use only

  • Uses

    For the temporary relief of minor pain.

  • Tibetree 5 PDP.jpg

    Tibetree 5 PDP.jpg

    Tibetree 5 PDP.jpg

  • INGREDIENTS AND APPEARANCE
    TIBETREE PAIN RELIEVEING PLASTER 
    camphor plaster
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66506-180
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ZANTHOXYLUM BUNGEANUM FRUIT RIND (UNII: K447936H97)  
    CURCUMA LONGA WHOLE (UNII: W5488JUO8U)  
    CARTHAMUS TINCTORIUS FLOWER BUD (UNII: B86IS274O0)  
    PHLOMOIDES ROTATA WHOLE (UNII: 7CEU5N8573)  
    MYRICARIA PANICULATA STEM (UNII: 4C36LPC9I2)  
    OXYTROPIS CHILIOPHYLLA WHOLE (UNII: 9T7BW444B3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66506-180-035 in 1 PACKAGE04/30/2019
    1NDC:66506-180-021.2 g in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/30/2019
    Labeler - Tibet Cheezheng Tibetan Medicine Co. Ltd. (529074851)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cheezheng Tibetan Medicine Co. Ltd.529074851manufacture(66506-180) , label(66506-180)
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