Label: CHLORASEPTIC- menthol and benzocaine lozenge

  • NDC Code(s): 67172-021-18
  • Packager: Prestige Brands Holdings, Inc.
  • 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 24, 2023

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts 

  • Active ingredients (in each lozenge)

    Benzocaine 6 mg

    Menthol 10 mg

  • Purpose

    Oral pain reliever

    Oral pain reliever

  • Uses

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

  • 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 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. If a skin reaction occurs, stop use and seek medical help right away.

    Sore Throat Warning Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a doctor promptly. Do not use more than 2 days or give to children under 6 years of age unless directed by a doctor.

    Do not use

    • for teething
    • in children under 6 years of age

    When using this product

    do not exceed recommended dosage.

    Stop use and ask a dentist or doctor if:

    • sore mouth symptoms do not improve in 7 days
    • irritation, pain or redness persists or worsens
    • swelling, rash or fever develops

    If pregnant or breast-feeding,

    ask a health care professional before use.  

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    • Adults and children 6 years and older: Take 1 lozenge every 2 hours as needed. Allow lozenges to dissolve slowly in the mouth.
    • Children under 6 years: Do not use.
  • Other information

    • store between 15 - 30C (59 - 86F)
    • protect from moisture
    • check expiration date before using
  • Inactive ingredients

    Corn syrup, FD&C red no. 40, flavor, glycerin, soy lecithin, sucrose, water

  • Questions?

    1-800-552-7932

  • PRINCIPAL DISPLAY PANEL

    Chloraseptic®

    Menthol | Benzocaine Oral Pain Reliever Lozenges

    Cherry | 18 lozenges

    Chloraseptic®
Menthol | Benzocaine Oral Pain Reliever Lozenges

Cherry | 18 lozenges

  • INGREDIENTS AND APPEARANCE
    CHLORASEPTIC 
    menthol and benzocaine lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67172-021
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 mg
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE6 mg
    Inactive Ingredients
    Ingredient NameStrength
    CORN SYRUP (UNII: 9G5L16BK6N)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    SUCROSE (UNII: C151H8M554)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorredScoreno score
    ShapeOVALSize4mm
    FlavorCHERRYImprint Code C
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67172-021-181 in 1 CARTON08/01/2010
    118 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 finalpart35608/01/2010
    Labeler - Prestige Brands Holdings, Inc. (159655021)