Label: ANTIPHLAMINE PAIN RELIEVING- flurbiprofen patch

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated October 13, 2015

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  • ACTIVE INGREDIENT

    Active Ingredient: Flurbiprofen 33mg

  • INACTIVE INGREDIENT

    Inactive Ingredients: Methylparaben, Propylparaben, L-menthol, Propylene Glycol, Glycerin, Titanium Oxide, Kaolin, Sodium Carboxymethyl Cellulose, Dihydroxyaluminum Aminoacetate Hydrate, Disodium Edetate Hydrate, Gelatin, Sodium Polyacrylate, Polyacrylic Acid solution, Ferric Oxide, Butylhydroxytoluene, Purified water, felt, attachment felt, Polyethyleneterephthalate Separator, propyleneglycol monocaprylate, Sorbitan Oleate, tartaric acid

  • PURPOSE

    Purpose: Topical Analgesic

  • WARNINGS

    Warnings: For external use only Ask a doctor before use if you have redness over the affected area. Do not use: on wounds or damaged skin. Stop use and ask a doctor if excessive skin irritation occurs. Do not use if you are pregnant or breast feading. Do not use if you are allergic to any of the ingredients(Aspirin, Flurbiprofen) and stop use if rash, itching or allergic reaction develops.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children: Keep out of reach of children to avoid accidental ingestion. If swallowed, get medical help or contact a Poison Control Center immediately. Children under 12 years of age: Ask a doctor Children under 30 month: Do not use

  • INDICATIONS & USAGE

    Indications & Usage: For the temporary relief of Shoulder Pain, Backache, Neuralgia, Arthralgia, Sore Muscles, Sprains, Bruises, Rheumatic Pain, and Fracture Pain.

  • DOSAGE & ADMINISTRATION

    Dosage & Administration: Attach to the affected part, twice daily

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of cello pack

  • INGREDIENTS AND APPEARANCE
    ANTIPHLAMINE PAIN RELIEVING 
    flurbiprofen patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69642-1300
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Flurbiprofen (UNII: 5GRO578KLP) (FLURBIPROFEN - UNII:5GRO578KLP) Flurbiprofen33 mg  in 5 
    Inactive Ingredients
    Ingredient NameStrength
    Methylparaben (UNII: A2I8C7HI9T)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69642-1300-15 in 1 CELLO PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other09/01/2015
    Labeler - HANUL TRADING CO., LTD. (689512982)
    Registrant - HANUL TRADING CO., LTD. (689512982)
    Establishment
    NameAddressID/FEIBusiness Operations
    HANUL TRADING CO., LTD.689512982repack(69642-1300)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dae Hwa Pharm Co., Ltd.688004324manufacture(69642-1300)
    Establishment
    NameAddressID/FEIBusiness Operations
    KOCO TRADING CO., INC.079457993wholesale drug distributor(69642-1300)
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