Label: ORAL PAIN RELIEF GEL- benzocaine 20% gel

  • NDC Code(s): 81417-001-01
  • Packager: Sled Distribution, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 15, 2024

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  • ACTIVE INGREDIENT

    Active ingredient

    Benzocaine 20% (w/w)

  • PURPOSE

    Purpose

    Oral anesthetic

  • INDICATIONS & USAGE

    Uses temporary relief of minor pain and sore mouth associated with toothache, minor dental procedures and irritations from dentures or orthodontic appliances.

  • WARNINGS

    Warnings

    For oral use only.

  • STOP USE

    Stop use and ask a doctor if get any discomfort.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

    Directions adults and children 2 years and older: dry affected area and apply medication undiluted. Use up to 4 times daily but not more than every two hours, or as directed by a dentist or a doctor.

  • INACTIVE INGREDIENT

    Inactive ingredients

    Polyethylene Glycol, Fragrance

  • PRINCIPAL DISPLAY PANEL

    image of pouch label

  • INGREDIENTS AND APPEARANCE
    ORAL PAIN RELIEF GEL 
    benzocaine 20% gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81417-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81417-001-010.75 g in 1 POUCH; Type 0: Not a Combination Product08/29/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01708/29/2022
    Labeler - Sled Distribution, LLC (079772888)
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