Label: ORAL GEL ORAL PAIN RELIEF- benzocaine benzalkonium chloride gel

  • NDC Code(s): 83650-101-01
  • Packager: Savvy Care and Cosmetics
  • Category: HUMAN OTC DRUG LABEL

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 September 22, 2023

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  • Active Ingredient

    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 infectionin minor oral irritation

  • Warnings

    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: should be supervised in the use of this product ■ children under 2 years of age: ask a physician or health care provider

  • 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

  • Package Label

    image description

  • INGREDIENTS AND APPEARANCE
    ORAL GEL  ORAL PAIN RELIEF
    benzocaine benzalkonium chloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83650-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE20 g  in 100 g
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBIC ACID (UNII: X045WJ989B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83650-101-0142.5 g in 1 TUBE; Type 0: Not a Combination Product09/22/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35609/22/2023
    Labeler - Savvy Care and Cosmetics (915039748)
    Establishment
    NameAddressID/FEIBusiness Operations
    Savvy Care and Cosmetics915039748manufacture(83650-101)