Label: 4X MEDICATED GUM CREAM- benzocaine cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 21, 2025

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

  • ACTIVE INGREDIENT

    Benzalkonium chloride 0.13%

    Benzocaine 20%

    Menthol 0.26%

    Zinc chloride 0.15%

  • PURPOSE

    Oral antiseptic

    Oral pain reliever

    Oral pain reliever

    Oral astringent

  • INDICATIONS & USAGE

    • for the temporary relief of pain due to minor irritation or injury of the mouth and gums
    • first aid to help prevent infection in minor oral irritation
  • DOSAGE & ADMINISTRATION

    • cut open tip of tube on score mark
    • adults and children 2 years of age and older: apply to affected area 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
  • 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 * more than directed * for more than 7 days unless told to do so by a dentist or doctor * for teething * in children under 2 years of age

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

  • OTHER SAFETY INFORMATION

    • do not use if tip is cut prior to opening
    • avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying
  • INACTIVE INGREDIENT

    ammonium glycyrrhizate, flavor, PEG-8, PEG-75, sodium saccharin, sorbic acid, titanium dioxide

  • PRINCIPAL DISPLAY PANEL

    Albertsons_4XMed_Cream_CtnCF_2821621R2

  • INGREDIENTS AND APPEARANCE
    4X MEDICATED GUM CREAM 
    benzocaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-621
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM0.25 g  in 100 g
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE20 g  in 100 g
    ZINC CHLORIDE (UNII: 86Q357L16B) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.15 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SORBIC ACID (UNII: X045WJ989B)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
    Product Characteristics
    Colorwhite (Cloudy white to yellow) Score    
    ShapeSize
    FlavorWINTERGREENImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21130-621-199.4 g in 1 TUBE; Type 0: Not a Combination Product05/07/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01705/07/2021
    Labeler - Albertsons (009137209)
    Registrant - Lornamead Products (119559733)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lornamead Products119559733manufacture(21130-621) , pack(21130-621)