Label: RITE AID PROFESSIONAL STRENGTH- benzocaine liquid

  • NDC Code(s): 11822-5340-1, 11822-5340-8
  • Packager: Rite Aid
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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

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

  • Active ingredient

    Benzocaine 20.0%  ...................................................................... Oral anesthetic / analgesic

  • Use

    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

    For oral use only
    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
    When using this product Do not use for more than 7 days unless told to do so by a dentist or doctor If sore mouth symptoms do not improve in 7 days; if irritation, pain or redness persists or worsens; or, if swelling, rash or fever develops, see your doctor or dentist promptly. Do not exceed recommended dosage.

    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 12 years of age should be supervised in
    the use of this product. children under 2 years of age:ask a dentist or doctor

  • DOSAGE & ADMINISTRATION

    • 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: consult a dentist or doctor

  • Other Information

    do not purchase if package has been opened
    store at 20 - 25 C (68-77F)
    close cap tightly after use to avoid evaporation
    avoid contact with eyes
    avoid contact with clothing and household furniture surfaces to avoid 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, Octylacrylamideacrylates/
    butylaminoethyl/methacrylate
    Copolymer, Oleth-10, PEG-6, Propylene
    Glycol, Ricinus Communis (Castor)
    Seed Oil, SD Alcohol 38B, Sucralose,
    Tannic Acid.

  • PRINCIPAL DISPLAY PANEL



    Bottle

    bottle label


    Blister

    blister label

  • INGREDIENTS AND APPEARANCE
    RITE AID  PROFESSIONAL STRENGTH
    benzocaine liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-5340
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE20 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MENTHOL (UNII: L7T10EIP3A)  
    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)  
    WATER (UNII: 059QF0KO0R)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    BENZOIN RESIN (UNII: GK21SBA74R)  
    Product Characteristics
    Coloryellow (orange to reddish orange) Score    
    ShapeSize
    FlavorMINT (Mint Flavor #25797) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-5340-81 in 1 BLISTER PACK01/11/2023
    1NDC:11822-5340-114.17 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B01/01/2014
    Labeler - Rite Aid (014578892)
    Registrant - Lornamead (080046418)
    Establishment
    NameAddressID/FEIBusiness Operations
    CSR Cosmetic Solutions243501959manufacture(11822-5340) , pack(11822-5340)