Label: HEB MOUTH SORE RELIEF- benzalkonium chloride, benzocaine, zinc chloride 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 11, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Benzalkonium chloride 0.02%

    Benzocaine 20%

    Zinc chloride 0.1%

  • PURPOSE

    Purpose

    Oral Antiseptic

    Oral Pain Reliever

    Oral Astringent

  • INDICATIONS & USAGE

    Uses

    temporarily relieves of pain caused by:

    • canker sores
    • cold sores
    • fever blisters
    • minor irritation of the mouth and gums
    • to help protect against infection in minor oral irritation
  • WARNINGS

    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 the 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, fever develops
    • irritation, pain or redness persist or worsen
    • sore mouth 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

    Directions

    • 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 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

    Inactive ingredients Allantoin,Carbomer, Edetate Disodium, Mentha Piperata (Peppermint Oil), Polyethylene Glycol, Polysorbate 60, Propylene Glycol, Propyl Gallate, Purified Water, PVP, Sodium Saccharin, Sorbic Acid, Stearyl Alcohol.

  • QUESTIONS

    Questions or Comments? Call 1-877-777-2473

  • SPL UNCLASSIFIED SECTION

    MADE WITH PRIDE AND CARE FOR H-E-B®

    SAN ANTONIO, TX 78204

  • PRINCIPAL DISPLAY PANEL

    H-E-B

    MOUTH SORE RELIEF

    FAST-ACTING GEL

    TRIPLE MEDICATED

    ORAL PAIN RELIEVER/ANTISEPTIC/ASTRINGENT

    NET WT 0.42 OZ (11.9 g)

    HEB MOUTH SORE GEL 2821343-1R2

  • INGREDIENTS AND APPEARANCE
    HEB MOUTH SORE RELIEF 
    benzalkonium chloride, benzocaine, zinc chloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-312
    Route of AdministrationTOPICAL
    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 CHLORIDE0.02 g  in 100 g
    ZINC CHLORIDE (UNII: 86Q357L16B) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    ALLANTOIN (UNII: 344S277G0Z)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBIC ACID (UNII: X045WJ989B)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    WATER (UNII: 059QF0KO0R)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    Product Characteristics
    Colorwhite (white/clear to yellow to slight pink/orange) Score    
    ShapeSize
    FlavorPEPPERMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37808-312-291 in 1 CARTON02/19/2019
    111.9 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 finalpart35602/19/2019
    Labeler - HEB (007924756)
    Registrant - Lornamead Inc. (080046418)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lornamead Inc.080046418manufacture(37808-312)
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