Label: ORAL PAIN RELIEF- benzocaine and benzalkonium chloride gel

  • NDC Code(s): 52000-060-02
  • Packager: Universal Distribution Center LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 4, 2024

If you are a consumer or patient please visit this version.

  • Active Ingredients

    Benzocaine 20%

    Benzalkonium Chloride 0.1%

  • Purpose

    Oral pain reliever

    Antiseptic

  • Use

    ■ for the temporary relief of pain due to toothaches

    ■ to help protect against infection in minor oral irritation

  • Warnings

    Methemoglobinemia warning: Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduce the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops: pale, gray, or blue colored skin (cyanosis)
    • headache
    • rapid heart rate
    • shortness of breath
    • dizziness or lightheadness
    • fatigue or lack of energy

    Allergy alert:do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine or other "caine" anesthetics

  • Do not use

    ■ more than directed

    ■ for more than 7 days unless directed by a physician or healthcare provider

  • Stop use and ask a physician if

    ■ swelling, rash or fever develops

    ■ irritation, pain or redness persists or worsens

    ■ symptoms do not improve in 7 days

  • Keep out of reach of children

    In case of overdose or allergic reaction get medical help or contact a Poison Control Center right away.

  • Directions

    ■ adults and children 2 years of age and over: apply a small amount of the product to the cavity and around the gum surrounding the teeth Use up to 4 times daily or as directed by a physician or healthcare provider

    ■ children under 12 years of age: should be supervised in the use of this product

    ■ children under 2 years of age: Do not use

  • Other information

    ■ this preparation is intended for use in cases ot toothache, only as a temporary expedient until a physican can be consulted

    ■ do not use continuously

    ■ avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying

    ■ do not use if tube seal under cap is broken, missing or if the tube tip is cut prior to opening

  • Inactive ingredients

    ammonium glycyrrhizate, flavor, polyethylene glycol, sodium saccharin, sorbic acid, purified water, FD&C Yellow#5, FD&C Red#40

  • Package Label

    Oral Pain Relief Gel

    NET WT. 0.5 oz (14 g)

    oralgel-2

  • INGREDIENTS AND APPEARANCE
    ORAL PAIN RELIEF 
    benzocaine and benzalkonium chloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52000-060
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE0.2 g  in 1 g
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.01 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBIC ACID (UNII: X045WJ989B)  
    WATER (UNII: 059QF0KO0R)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52000-060-021 in 1 CARTON05/01/2024
    114 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02201/05/2024
    Labeler - Universal Distribution Center LLC (019180459)