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
  • 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 July 20, 2022

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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 not finalpart35601/01/2012
    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 not finalpart35609/01/2012
    Labeler - Prestige Brands Holdings, Inc. (159655021)
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