Label: CHLORASEPTIC SORE THROAT MAX LIQUID CENTER- menthol and benzocaine lozenge

  • 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 November 19, 2010

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    (in each lozenge)

    Benzocaine 15 mg

  • Purpose

    Oral Anesthetic/Analgesic

  • Active Ingredients

    (in each lozenge)

    Menthol 10 mg

  • Purpose

    Oral Anesthetic/Analgesic

  • 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.

    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 administer to children under 6 years of age unless directed by a doctor.

    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 or accidental poisoning, get medical help or contact a Poison Control Center right away.

  • Directions

    • Adults and children 6 years of age and over: Take 1 lozenge every 2 hours as needed. Allow lozenges to dissolve slowly in the mouth.
    • Children under 6 years of age: Consult a doctor or dentist.
  • Other Information

    • Store between 59ºF and 86ºF (15ºC - 30ºC).
    • Protect from moisture.
    • Check expiration date before using.
    • Tamper Evident: Do not use if blister package with “Chloraseptic®” name has been disturbed or opened.
  • Inactive Ingredients

    Corn Syrup, FD&C Blue #1, FD&C Red #40, Flavor, Glycerine, Propylene Glycol, Soy Lecithin, Sucrose, Water

  • Questions?

    1-800-552-7932 or www.chloraseptic.com

  • PRINCIPAL DISPLAY PANEL

    Chloraseptic® Max
    SORE THROAT FAST ACTING RELIEF
    15 lozenges | Wild Berries

    PRINCIPAL DISPLAY PANEL Chloraseptic® Max SORE THROAT FAST ACTING RELIEF 15 lozenges | Wild Berries

  • INGREDIENTS AND APPEARANCE
    CHLORASEPTIC SORE THROAT MAX LIQUID CENTER 
    menthol and benzocaine lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67172-174
    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) BENZOCAINE15 mg
    Inactive Ingredients
    Ingredient NameStrength
    CORN SYRUP (UNII: 9G5L16BK6N)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    SUCROSE (UNII: C151H8M554)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Product Characteristics
    ColorREDScore2 pieces
    ShapeOVALSize4mm
    FlavorBERRYImprint Code C
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67172-174-611 in 1 CARTON
    115 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34108/01/2010
    Labeler - Prestige Brands Holdings, Inc. (159655021)
    Establishment
    NameAddressID/FEIBusiness Operations
    BestSweet, Inc.002149136MANUFACTURE
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