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ONE TOUCH ADVANCED TOPICAL ANESTHETIC GEL (HAGER WORLDWIDE, INC.)

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GEL 1 JAR in 1 BOX (62565-901-01) > 32 g in 1 JAR Label Information

Complete ONE TOUCH ADVANCED TOPICAL ANESTHETIC GEL Information

  • PRINCIPAL DISPLAY PANEL

    Caution: Rx Only.
    Do not use in eyes.  Keep out of reach of children.

    Directions: Read package insert.
    Press top of container to dispense desired amount.
    Dispense 200 mg of gel (a bead approximately
    1/4 to 1/2 inches long) by gently depressing the
    pump.  Dispensing a bead in excess of 400 mg is
    contraindicated.  Spread thinly and evenly over the
    desired area using a cotton swab.

    Active Ingredients: Benzocaine 14.0%,
    Butamben 2.0%, Tetracaine Hydrochloride 2.0%
    Inactive Ingredients: Benzalkonium Chloride
    0.5%, Cetyl Dimethyl Ethyl Ammonium Bromide
    0.005%, in a bland water-soluble base.
    NDC 62565-901-01
    OneTouch
    Advanced


    Topical Anesthetic Gel

    OneTouch Advanced
    is indicated for anesthesia of
    accessible mucous membrane.


    Cool Mint
    Net Wt. 32 g


    Store in a cool dry place.





    Manufactured for:
    HAGER
    WORLDWIDE
    Odessa, FL  33556 USA


    Item #6256590101



    Made in U.S.A.   Rev. 05/09
    Image of principal jar label

  • DESCRIPTION

    OneTouch
    Advanced

    Topical Anesthetic Gel                                                                                                                                                                           Rx
    Only
    Active Ingredients:
    Benzocaine
    14.0%
    Butamben
    2.0%
    Tetracaine Hydrochloride
    2.0%

  • INACTIVE INGREDIENT

    Inactive Ingredients:
    Benzalkonium chloride
    0.5%
    Cetyl Dimethyl Ethyl Ammonium Bromide
    0.005%
    In bland, water-soluble base.


  • MECHANISM OF ACTION

    Action
    The onset of OneTouch Advanced-produced anesthesia is rapid (approximately
    30 seconds) and the duration of anesthesia is typically 30-60 minutes, when
    used as directed. This effect is due to the rapid onset, but short duration of
    action of Benzocaine coupled with the slow onset, but extended duration of
    Tetracaine HCI and bridged by the intermediate action of Butamben.

    It is believed that all of these agents act by reversibly blocking nerve conduc-­
    tion. Speed and duration of action is determined by the ability of the agent to
    be absorbed by the mucous membrane and nerve sheath and then to diffuse
    out, and ultimately be metabolized (primarily by plasma cholinesterases) to inert
    metabolites which are excreted in the urine.
  • INDICATIONS & USAGE

    Indications
    OneTouch Advanced Gel is a topical anesthetic indicated for the production
    of anesthesia of all accessible mucous membrane except the eyes. OneTouch
    Advanced Gel is indicated for use to control pain in the mouth.


  • DOSAGE & ADMINISTRATION

    Dosage and Administration
    Only a limited quantity is OneTouch Advanced Gel is required for anesthesia.

    Dispense 200 mg of gel (a bead approximately 1/4 to 1/2 inches long) by gently
    depressing the pump.  Dispensing a bead of gel in excess of 400 mg is contrain-­
    dicated. Spread thinly and evenly over the desired area using a cotton swab.

    An appropriate pediatric dosage has not been established for OneTouch Ad-­
    vanced Gel.

    Dosages should be reduced in the debilitated elderly, acutely ill, and very young
    patients.

    Tissue need not be dried prior to application of OneTouch Advanced Gel. One-
    Touch Advanced Gel should be applied directly to the site where pain control is
    required. Anesthesia is produced within one minute with an approximate duration
    of thirty minutes. Each 200 mg dose of OneTouch Advanced Gel contains 28 mg
    of benzocaine, 4 mg of butamben and 4 mg of tetracaine HCI.


  • ADVERSE REACTIONS

    Adverse Reactions
    Hypersensitivity Reactions:
    Unpredictable adverse reactions (i.e. hypersensi-­
    tivity, including anaphylaxis) are extremely rare.

    Localized allergic reactions may occur after prolonged or repeated use of any
    aminobenzoate anesthetic. The most common adverse reaction caused by
    local anesthetics is contact dermatitis characterized by erythema and pruritus
    that may progress to vesiculation and oozing. This occurs most commonly in
    patients following prolonged self-medication, which is contraindicated. If rash,
    urticaria, edema, or other manifestations of allergy develop during use, the drug
    should be discontinued. To minimize the possibility of a serious allergic reaction,
    OneTouch Advanced Gel should not be applied for prolonged periods except
    under continual supervision. Dehydration of the epithelium or an escharotic ef-­
    fect may also result from prolonged contact.
  • PRECAUTIONS

    Precaution: On rare occasions, methemoglobinemia has been reported in
    connection with the use of benzocaine-containing products. Care should be
    used not to exceed the maximum recommended dosage (see Dosage and
    Administration). If a patient becomes cyanotic, treat appropriately to counteract
    (such as with methylene blue, if medically indicated).


  • PREGNANCY

    Use in Pregnancy: Safe use of One Touch Advanced Gel has not been
    established with respect to possible adverse effects upon fetal development.
    Therefore, OneTouch Advanced Gel should not be used during early pregnancy,
    unless in the judgement of a physician, the potential benefits outweigh the un-­
    known hazards. Routine precaution for the use of any topical anesthetic should
    be observed when OneTouch Advanced Gel is used.
  • CONTRAINDICATIONS

    Contraindications
    OneTouch Advanced Gel is not suitable and should never be used for injection.
    Do not use on the eyes. To avoid excessive systemic absorption, OneTouch
    Advanced Gel should not be applied to large areas of denuded or inflamed
    tissue. OneTouch Advanced Gel should not be administered to patients who are
    hypersensitive to any of its ingredients or to patients known to have cholinest-­
    erase deficiencies. Tolerance may vary with status of the patient.
     
    OneTouch Advanced Gel should not be used under dentures or cotton rolls, as
    retention of the active gel ingredients under a denture or cotton roll could pos-­
    sibly cause an escharotic effect. Routine precaution for the use of any topical
    anesthetic should be observed when using OneTouch Advanced Gel.


  • HOW SUPPLIED

    How-Supplied
    OneTouch Advanced Gel, 32 g jar

    Cool Mint
    NDC 62565-901-01
    Strawberry Ice
    NDC 62565-902-01
    Bubble Gum
    NDC 62565-903-01
    Cherry
    NDC 62565-904-01
    Manufactured for
    HAGER
    WORLDWIDE

    13322 Byrd Drive
    Odessa, FL 33556 USA

    Made in U.S.A.        Rev. 6/09


  • INGREDIENTS AND APPEARANCE
    ONE TOUCH ADVANCED TOPICAL ANESTHETIC GEL  COOL MINT
    benzocaine, butamben, tetracaine hydrochloride gel
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62565-901
    Route of Administration TOPICAL, DENTAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 28 mg  in .2 g
    BUTAMBEN (UNII: EFW857872Q) (BUTAMBEN - UNII:EFW857872Q) BUTAMBEN 4 mg  in .2 g
    TETRACAINE HYDROCHLORIDE (UNII: 5NF5D4OPCI) (TETRACAINE - UNII:0619F35CGV) TETRACAINE HYDROCHLORIDE 4 mg  in .2 g
    Inactive Ingredients
    Ingredient Name Strength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) 1 mg  in .2 g
    Product Characteristics
    Color green (GREEN) Score     
    Shape Size
    Flavor MINT (COOL MINT) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:62565-901-01 1 in 1 BOX
    1 32 g in 1 JAR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 02/01/2009
    Labeler - HAGER WORLDWIDE, INC. (009277971)
    Registrant - HAGER WORLDWIDE, INC. (009277971)
    Establishment
    Name Address ID/FEI Business Operations
    HAGER WORLDWIDE, INC. 009277971 manufacture