Label: CHLORASPETIC- menthol and benzocaine lozenge

  • NDC Code(s): 67172-023-18
  • 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 October 28, 2022

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  • 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

    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 of age and older: Take 1 lozenge every 2 hours as needed. Allow lozenges to dissolve slowly in the mouth.

    Children under 6 years of age: Do not use.

  • Other information

    • Contains FD&C yellow no. 5 (tartrazine) as a color additive.
    • Store between 15○C - 30○C (59○F - 86○F)
    • Protect from moisture.
    • Check expiration date before using.
  • Inactive ingredients

    corn syrup, FD&C yellow no. 5,, glycerin, honey, propylene glycol, soy lecithin, sucrose, water

  • Questions

    1-800-552-7932 Chloraseptic.com

  • PRINCIPAL DISPLAY PANEL

    Chloraseptic®

    Sore throat

    18 lozenges | Honey Lemon With real honey

    PRINCIPAL DISPLAY PANEL Chloraseptic® Sore throat 18 lozenges | Honey Lemon With real honey

  • INGREDIENTS AND APPEARANCE
    CHLORASPETIC 
    menthol and benzocaine lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67172-023
    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 YELLOW NO. 5 (UNII: I753WB2F1M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    SUCROSE (UNII: C151H8M554)  
    WATER (UNII: 059QF0KO0R)  
    HONEY (UNII: Y9H1V576FH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeOVALSize4mm
    FlavorLEMON (Honey Lemon) Imprint Code C
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67172-023-183 in 1 CARTON08/01/2010
    16 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)
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