Label: ANESTHETIC LOZENGES HONEY LIME FLAVORS- benzocaine,menthol lozenge

  • 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 May 2, 2023

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

  • Active Ingredient

    Benzocaine   15 mg

    Menthol        2.6 mg

  • Purpose

    Oral anesthetic

  • Uses

    Temporarily relieves occasional minor irritation, pain, sore throat and sore mouth.

  • Warning

    Methemoglobinemia warning
    Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduced 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, grey, or blue colored skin (Cyanosis)
    • Headache
    • Rapid heart ache
    • Shortness of breath
    • Dizziness or light headedness
    • Fatigue or lack of energy

    Sore throat warning

    If sore throat is severe, persists for more than 2 days, is accompanied, or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, or if irritation, pain or redness persist or worsens, see your dentist or doctor promptly.

    Do not use

    • For teething
    • In children under 5 years of age

    Stop use and ask doctor if

    • Sore mouth symptoms do not improve in 7 days.


    If pregnant or breast-feeding, ask a health professional before use.


    Keep out of reach of children. In case of overdose, get medical help or contact Poison Control Center right away.

    Allergy alert : Do not use this product if you have a history of allergy to local anesthetic such as procaine, butacaine, benzocaine, or other "caine" anesthetics

  • KEEP OUT OF REACH OF CHILDREN

  • Directions

    Adults and children 5 years and older:

    Allow 1 lozenge to dissolve slowly in mouth. May be repeated every two hours as necessary or as directed by a doctor.

    Children under 5 years: Do not use.

  • Other Information

    • Store at room temperature
    • Protect from moisture.

    TEMPER EVIDENT PACKAGING. DO NOT USE IF OUTER BOX OR BLISTER IS OPENED OR DAMAGED.

  • Inactive ingredients

    Acesulfame k, Citric acid, Honey lime flavor, Liquid glucose, Sucrose, Tartaric acid, Tartrazine and Water

  • Product label

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  • INGREDIENTS AND APPEARANCE
    ANESTHETIC LOZENGES HONEY LIME FLAVORS 
    benzocaine,menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83348-002
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE15 mg
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.6 mg
    Inactive Ingredients
    Ingredient NameStrength
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    SUCROSE (UNII: C151H8M554)  
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    TARTARIC ACID (UNII: W4888I119H)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeROUNDSize18mm
    FlavorHONEY (Honey and Lime) Imprint Code NO
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83348-002-0110 in 1 CARTON04/15/2023
    19 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35604/15/2023
    Labeler - PRASON FOODS (861707089)
    Establishment
    NameAddressID/FEIBusiness Operations
    PRASON FOODS861707089manufacture(83348-002)