Label: OPAHL- benzocaine spray, metered

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

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Drug Label Information

Updated January 1, 2013

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  • Active Ingredient

    Benzocaine 20%......................................................Oral Anesthetic

  • Uses

    For the temporary relief of occasional minor irritation and pain associated with canker sores and minor dental procedures.

  • Warnings

    • Keep out of reach of children
    • If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center immediately.
    • Do not use if you have a history of allergy to local anesthetic such a procaine, butacaine, benzocaine or other "caine" anesthetics.
    • Flammable. Do not use near fire or flame. Avoid smoking during use.
    • Avoid spraying in eyes.
  • Dosage

    A single metered spray dispenses 50mg of Opahl-S Topical Anesthetic.

  • Directions

    • Do not exceed recommended dosage
    • Firmly insert extension tube into spray can valve and ensure it fits securely into the actuator opening
    • position the extension tube 1-2 inches from the affected area.
    • Spray 1/2 second (press and immediately release the actuator)
    • Anesthesia is accomplished in approximately 20 seconds.
  • Other Information

    • Do not store at room temperature above 49oC (120oF)
    • For professional use only. Federal US Law prohibits dispensing without a prescription
  • Inactive ingredients

    Denatured Alcohol, Flavor, Polyethylene Glycol, Sodium Saccharin, Hydrocarbon Propellant (Isobutane and Propane)

  • Label

    Entire Label

  • INGREDIENTS AND APPEARANCE
    OPAHL 
    benzocaine spray, metered
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:53045-125
    Route of AdministrationORAL, TOPICAL, DENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE12 g  in 60 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    ALCOHOL (UNII: 3K9958V90M)  
    PROPANE (UNII: T75W9911L6)  
    ISOBUTANE (UNII: BXR49TP611)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorSPEARMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53045-125-6060 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/01/2013
    Labeler - Dharma Research, inc. (078444642)
    Registrant - Dharma Research, inc. (078444642)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dharma Research, inc.078444642manufacture(53045-125)
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