Label: DG 4X MEDICATED TOOTH AND 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

    Uses

    • for the temporary relief of pain due to minor irritation or njury of the mouth and gums
    • first aid to help prevent inceftion in mior 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 develop

    • 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

    • symptoms do not improve in 7 days
    • swelling, rash or fever develops
    • irritation, pain or redness persists or worsens

    Keep out reach of children. In case of overdose or allergic reaction, get medical help or contact a Posion Control Center right away.

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    cut open tip of tube on score mark * adults and children 2 years of age and older: apply a small amount of product to teh cavity and around teh gum surrounding the teeth. Use up to 4 times daily or as directed by a dentist or doctor * children under 12 years of age should be supervised in teh use of this product * children under 2 years of age: do not use

  • OTHER SAFETY INFORMATION

    Other 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

    DG_4Xmedicated_cream_ctn_2821606R2

  • INGREDIENTS AND APPEARANCE
    DG 4X MEDICATED TOOTH AND GUM CREAM 
    benzocaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-660
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC CHLORIDE (UNII: 86Q357L16B) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.15 g  in 100 g
    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 FORM0.26 g  in 100 g
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE20 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
    AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBIC ACID (UNII: X045WJ989B)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorwhite (Cloudy White to Yellow) Score    
    ShapeSize
    FlavorWINTERGREENImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55910-660-091 in 1 CARTON10/28/2020
    19.4 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02210/28/2020
    Labeler - Dollar General (068331990)
    Registrant - Lornamead Products (119559733)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lornamead Products119559733manufacture(55910-660) , pack(55910-660)