Label: ASTONEA MAXIMUM STRENGTH ORAL PAIN RELIEF- benzocaine 20%, benzalkonium chloride 1% gel

  • NDC Code(s): 77338-201-01
  • Packager: ASTONEA LABS PRIVATE LIMITED
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 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 reduces 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 lightheadedness ■ 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, benzocaine, or other "caine" anesthetics

  • DO NOT USE

    Do not use

    • more than directed
    • for more than 7 days unless directed by a physician or healthcare provider
  • ASK DOCTOR

    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

    KEEP OUT OF REACH OF CHILDREN:

    In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away (1-800-222-1222)

  • DOSAGE & ADMINISTRATION

    Directions

    • Adults and children 2 years of age and over -Apply a small amount of 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- Ask a physician or healthcare provider
  • Other information

    • this preparation is intended for use in cases of toothache, only as a temporary expedient until a physician 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
    • store at 20-25C (68-77F)
  • Inactive ingredients


    aloe vera leaf, butylated hydroxytoluene, carbomer, cetyl alcohol, cholecalciferol, edetate disodium anhydrous, ethylhexylglycerin & phenoxyethanol, glycerol monostearate, isopropyl myristate, isopropyl palmitate, isopropyl stearate, light mineral oil, PEG 100
    stearate, PEG 4000, propylene glycol, sodium benzoate, sodium hydroxide, sodium laureth sulfate, sodium metabisulfite, sodium sulfite, vitamin A palmitate, vitamin E, water

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    ASTONEA MAXIMUM STRENGTH ORAL PAIN RELIEF 
    benzocaine 20%, benzalkonium chloride 1% gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77338-201
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg  in 1 g
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    ISOPROPYL STEARATE (UNII: 43253ZW1MZ)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77338-201-011 in 1 CARTON02/01/2022
    19.35 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01302/01/2022
    Labeler - ASTONEA LABS PRIVATE LIMITED (878533295)