Label: 2X MED LIQ- benzocaine liquid

  • NDC Code(s): 49354-375-58
  • Packager: CSR Cosmetic Solutions
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated September 2, 2021

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

  • ACTIVE INGREDIENT

    Benzocaine 20%

    Menthol 0.1%

  • PURPOSE

    Oral anesthetic

    Oral anesthetic

  • INDICATIONS & USAGE

    temporarily relieves pain associated with the following mouth and gum irritations: * toothache * sore gums * canker sores * braces * minor dental procedures

  • WARNINGS

    Methemoglobinemia warning: use of this product may cause methemoglobinemia, a serious condition that must be treated prompty 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, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Adults and children 2 years of age and older: * apply to affected area using applicator tip * use up to 4 times daily or as directed by a dentist or doctor * children under 12 years of age should be supervised in the use of this product. children under 2 years of age: do not use

  • OTHER SAFETY INFORMATION

    do not use if package has been opened * store ar 20-25°C (68-77°F)

  • INACTIVE INGREDIENT

    alcohol, flavor, polyethylene glycol, red 40, sodium saccharin, water, yellow 5

  • PRINCIPAL DISPLAY PANEL

    CVS Carton Artwork

  • INGREDIENTS AND APPEARANCE
    2X MED LIQ 
    benzocaine liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49354-375
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE20 mg  in 100 mL
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM0.1 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Product Characteristics
    Colorred (Red/Orange) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49354-375-581 in 1 CARTON09/01/2021
    114.7 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35609/01/2021
    Labeler - CSR Cosmetic Solutions (243501959)
    Registrant - Lornamead (080046418)
    Establishment
    NameAddressID/FEIBusiness Operations
    CSR Cosmetic Solutions243501959pack(49354-375) , manufacture(49354-375)