Label: CHLORASEPTIC WARMING SORE THROAT- benzocaine lozenge

  • NDC Code(s): 67172-017-02, 67172-018-02
  • Packager: Prestige Brands Holdings, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 25, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    (in each lozenge)

    Benzocaine 15 mg

  • Purpose

    Oral Anesthetic/Analgesic

  • Uses

    Temporarily relievesoccasional 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 3 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 doctor before use.

    Keep out of reach of children.

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

  • Directions

    • Adults and children 3 years of age and over: Take 1 lozenge every 2 hours as needed. Allow lozenges to dissolve slowly in the mouth.
    • Children under 3 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.
    • Contains FD&C yellow no. 5 (tartrazine) as a color additive.
  • Inactive ingredients

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

  • Questions?

    1-800-552-7932 Chloraseptic.com

    Drug Facts

  • Active Ingredients

    (in each lozenge)

    Benzocaine 15 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 3 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 doctor before use.

    Keep out of reach of children.

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

  • Directions

    • Adults and children 3 years of age and over: Take 1 lozenge every 2 hours as needed. Allow lozenges to dissolve slowly in the mouth.
    • Children under 3 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, Epigallocatechin Gallate (EGCG), FD&C Blue #1, FD&C Yellow #5, Flavor, Honey, Propylene Glycol, Soy Lecithin, Sucrose, Water

  • Questions?

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

  • PRINCIPAL DISPLAY PANEL


    Chloraseptic© 
    warming
    SORE THROAT
    FAST ACTING
    HONEY LEMON
    18 lozenges

    Chloraseptic© warming SORE THROAT FAST ACTING HONEY LEMON 18 lozenges

  • PRINCIPAL DISPLAY PANEL

    SOOTIHNG LIQUID CENTER
    Pharmacist #1 Recommended
    Chloraseptic warming SORE THROAT
    Benzocaine Oral Anesthetic | Analgesic Lo    zenges
    18 lozenges | Green Tea     with real honey

    SOOTIHNG LIQUID CENTER Pharmacist #1 Recommended Chloraseptic warming SORE THROAT Benzocaine Oral Anesthetic | Analgesic Lozenges 18 lozenges | Green Tea with real honey

  • INGREDIENTS AND APPEARANCE
    CHLORASEPTIC WARMING SORE THROAT 
    benzocaine lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67172-017
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE15 mg
    Inactive Ingredients
    Ingredient NameStrength
    CORN SYRUP (UNII: 9G5L16BK6N)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HONEY (UNII: Y9H1V576FH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeOVALSize4mm
    FlavorHONEYImprint Code C
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67172-017-021 in 1 CARTON01/01/2012
    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 DrugM02201/01/2012
    CHLORASEPTIC WARMING SORE THROAT 
    benzocaine lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67172-018
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE15 mg
    Inactive Ingredients
    Ingredient NameStrength
    CORN SYRUP (UNII: 9G5L16BK6N)  
    EPIGALLOCATECHIN GALLATE (UNII: BQM438CTEL)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    HONEY (UNII: Y9H1V576FH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorgreenScoreno score
    ShapeOVALSize4mm
    FlavorHONEY (Green Tea) Imprint Code C
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67172-018-021 in 1 CARTON09/01/2012
    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 DrugM02209/01/2012
    Labeler - Prestige Brands Holdings, Inc. (159655021)
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