Label: MOUTH SORE RELIEF PROFESSIONAL STRENGTH- benzocaine liquid

  • NDC Code(s): 59779-830-38, 59779-830-48
  • Packager: CVS Pharmacy
  • 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 December 9, 2022

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

  • Drug Facts

  • Active ingredient

    Benzocaine 20% (w/w)

  • Purpose

    Oral Anesthetic/Analgesic

  • Uses

    for the temporary relief of pain due to canker sores, minor irritation of the mouth and gums caused by dentures or orthodontic appliances, or minor injury of the mouth or gums

  • 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 developes: • pale, gray, or blue colored skin (cyanosis) • heache • 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 reacion occurs

    Keep out of reach of children.

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

  • Directions

    • to assure formation of long-lasting film coating, dry affected area and apply medication undiluted with applicator
    • allow a few seconds for coating to form
    • 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 Information

    • do not use if package has been opened
    • store at 20-25˚C (68-77°F)
    • close cap tightly after use to avoid evaporation
    • avoid contact with eyes
    • avoid contact with clothing and household/furniture surfaces to prevent possible staining
    • this is a personal care item, and should be used by one individual only

  • Inactive ingredients

    Benzyl Alcohol, Cetylpyridinium Chloride, Compound Benzoin Tincture, Dimethyl Isosorbide, Ethylcellulose, Flavor, Octylacrylamide/acrylates/butylaminoethyl/methacrylate Copolymer, Oleth-10, PEG-6, Propylene Glycol, Ricinus Communis (Castor)
    Seed Oil, SD Alcohol 38B, Sucralose,Tannic Acid.

  • SPL UNCLASSIFIED SECTION

    CVS Health

    PROFESSIONAL STRENGTH

    Mouth Sore Relief Liquid

    BENZOCAINE 20%

    Oral anesthetic

    Maximum pain relief

    For sores inside the mounth:

    • Canker sores
    • Denture pain
    • Irritation from braces
    • Gum pain

    0.5 FL OZ (14.7 mL)

    Distributed by: CVS Pharmacy, Inc.

    One CVS Drive, Woonsocket, RI 02895

    ©2019 CVS/pharmacy

    CVS.com ®

    1-800-SHOP CVS

    Made in Canada

    V-14931

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    MOUTH SORE RELIEF  PROFESSIONAL STRENGTH
    benzocaine liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-830
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)  
    TANNIC ACID (UNII: 28F9E0DJY6)  
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    OLETH-10 (UNII: JD797EF70J)  
    DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)  
    RICINUS COMMUNIS SEED (UNII: 7EK4SFN1TX)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    BENZOIN, (+/-) (UNII: L7J6A1NE81)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINT (Mint Flavor #25797) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-830-381 in 1 BLISTER PACK04/19/2011
    114.7 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    2NDC:59779-830-481 in 1 BLISTER PACK12/12/2022
    214.7 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35610/01/2009
    Labeler - CVS Pharmacy (062312574)
    Establishment
    NameAddressID/FEIBusiness Operations
    HK Kolmar Canada, Inc243501959manufacture(59779-830) , pack(59779-830)