Label: 4X MEDICATED TOOTHACHE AND GUM GEL- benzocaine gel, dentifrice

  • NDC Code(s): 56062-312-22
  • Packager: Publix Super Markets INC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 7, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Benzalkonium chloride 0.13%

    Benzocaine 20%

    Menthol 0.5%

    Zinc Chloride 0.15%

  • PURPOSE

    Oral antiseptic

    Oral pain reliever

    Oral astringent

  • INDICATIONS & USAGE

    temporary relief of pain due to toothache * to help protect against infection of 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 lightheadness

    fatique or lack of energy

    Alergy 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 dentist or doctor

    for teething

    in children under 2 years of age

  • STOP USE

    Stop use and ask a doctor if

    swelling, rash or fever develops

    irritation, pain or redness persists or worsens

    symptoms do not improve in 7 days

    allergic reaction occurs

  • 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.

  • DOSAGE & ADMINISTRATION

    Directions

    cut open tip of tube on score mark

    adults and children 2 years of age and older: 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 dentist or doctor.

    children between 2 and 12 years of age: ask a doctor before use. Should be supervised in the use of this product

    children under 2 years of age: do not use

    do not use if tip is cut prior to opening * this preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist can be consulted *do not use continuously *this formula will stay in place for extended duration of relief *avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying

  • INACTIVE INGREDIENT

    ammonium glycyrrhizate, blue 1, flavor, PEG-8, PEG-75, sodium saccharin, sorbic acid

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY:

    PUBLIX SUPER MARKETS, 3300 PUBLIX CORPORATE PARKWAY

    LAKELAND, FL 33811

  • PRINCIPAL DISPLAY PANEL

    PUBLIX SUPER MARKETS, INC

    4X MEDICATED GEL

    TOOTHACHE & GUM PAIN RELIEF

    • 20% Benzocaine to relieve oral pain
    • Kills harmful bacteria
    • Astringent to help prevent infection
    • Cools gum & relieves irritation

    Compare to the active ingredients in Orajel

    4X medicated for toothache & Gum gel*

    NET WT 0.25OZ (7 g)

    Publix 4X Medicated Toothache & Gum Gel

  • INGREDIENTS AND APPEARANCE
    4X MEDICATED TOOTHACHE AND GUM GEL 
    benzocaine gel, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56062-312
    Route of AdministrationORAL
    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 CHLORIDE0.13 g  in 100 g
    ZINC CHLORIDE (UNII: 86Q357L16B) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.15 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    SORBIC ACID (UNII: X045WJ989B)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
    Product Characteristics
    Colorblue (blue to Blue Green) Score    
    ShapeSize
    FlavorWINTERGREENImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:56062-312-221 in 1 CARTON09/01/2024
    17 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02209/01/2024
    Labeler - Publix Super Markets INC (006922009)
    Registrant - Lornamead Inc (080046418)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lornamead080046418pack(56062-312) , manufacture(56062-312)