Label: 3X MEDICATED MOUTH SORE GEL- benzocaine gel

  • 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 January 12, 2023

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  • ACTIVE INGREDIENT

    Active ingredients Purpose

    Benzocaine 20% . . . . . .Oral pain reliever

    Menthol 0.1% . . . . . . . . Oral pain reliever

    Zinc chloride 0.15% . . . .Oral astringent

  • PURPOSE

    Uses

    temporarily relieves pain caused by * canker sores * cold sores * fever blisters * minor irritation or injury of the mouth and gums

  • WARNINGS

    Methemoglobinemia warning: use of this product may cause methoglobinemia, 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

    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.

  • Directions

    Directions * cut open tip of tube on score mark * do not use if tip is cut prior to opening * 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 under 12 years of age should be supervised in the use of this product * children under 2 years of age: do not use

  • INACTIVE INGREDIENT

    allantoin, carbomer, disodium EDTA, flavor, polyethylene glycol, polysorbate 60, propylene glycol, pvp, sodium saccharin, sorbic acid, stearyl alcohol, water

  • PRINCIPAL DISPLAY PANEL

    Carton Artwork

  • INGREDIENTS AND APPEARANCE
    3X MEDICATED MOUTH SORE GEL 
    benzocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-691
    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
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM0.1 g  in 100 g
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE20 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
    SORBIC ACID (UNII: X045WJ989B)  
    ALLANTOIN (UNII: 344S277G0Z)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    POVIDONE K90 (UNII: RDH86HJV5Z)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Coloryellow (Clear to yellow tint) Score    
    ShapeSize
    FlavorWINTERGREENImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37808-691-191 in 1 CARTON06/02/2020
    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 not finalpart35606/02/2020
    Labeler - HEB (007924756)
    Registrant - Lornamead (126440440)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lornamead080046418manufacture(37808-691)
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