Label: PROSTADERM- 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 February 24, 2015

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  • ACTIVE INGREDIENT

    Active ingredients                         Purpose

    Camphor 3%...........................External analgesic

  • PURPOSE

    Uses For the temporary relief of pain

  • WHEN USING

    When using this product

    • Do not exceed recommended dosage
    • Do not use otherwise than as directed
    • Do not apply to wounds or damaged skin
  • ASK DOCTOR/PHARMACIST

    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
    • side effects occur. You may report side effects to FDA at
      1–800–FDA–1088.
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all drugs out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away
    Do not use otherwise than as directed

  • QUESTIONS

    • Questions?1-877-806-3569
  • DOSAGE & ADMINISTRATION

    Directions

    • Clean and dry affected area
    • Cut open pouch and remove patch
    • Remove Protective film and apply directly to the navel vertically
    • Do not apply to area with excessive hair. Highly adhesive patch, may hurt skin upon removal
    AdultsApply to affected area for 24-48 hours
    Children under 18 years of ageAsk a doctor

  • WARNINGS

    For external use only.

    Do not use otherwise than as directed

  • INDICATIONS & USAGE

    Uses For the temporary relief of pain.

  • INACTIVE INGREDIENT

    Cistanche Deserticola stem, Syzygium aromaticum whole, Commiphora myrrha resin, Corydalis bungeana whole, Dictamnus dasycarps root bark, Foeniculum vulgare whole, Synthetic moschus resin, Polyvinyl alcohol, Glycerol, Laurocapram

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  • INGREDIENTS AND APPEARANCE
    PROSTADERM 
    camphor plaster
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69446-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)3   in 100 
    Inactive Ingredients
    Ingredient NameStrength
    CISTANCHE DESERTICOLA STEM (UNII: 45BEI4ZF64)  
    SYZYGIUM AROMATICUM WHOLE (UNII: EY9MMA0P6Y)  
    COMMIPHORA MYRRHA WHOLE (UNII: UU81N77RI7)  
    CORYDALIS BUNGEANA WHOLE (UNII: 732H9A883V)  
    DICTAMNUS DASYCARPUS ROOT BARK (UNII: LA97176ILS)  
    FOENICULUM VULGARE WHOLE (UNII: J1UK54JBGH)  
    MOSCHUS MOSCHIFERUS MUSK SAC RESIN (UNII: 8KFK4W7KP7)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    GLYCEROL FORMAL (UNII: 3L7GR2604E)  
    LAUROCAPRAM (UNII: 1F3X9DRV9X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69446-100-011 in 1 PACKAGE02/24/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/24/2015
    Labeler - EZP Corporation (039212541)
    Registrant - Jinzhou Zijing Pharmaceutical Co. (527929247)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jinzhou Zijing Pharmaceutical Co., Ltd.527929247manufacture(69446-100)
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