Chloraseptic Sore Throat Liquid Center
FDA Label NDC 67172-013

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Prestige Brands Holdings, Inc. for the product Chloraseptic Sore Throat Liquid Center (NDC 67172-013). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, when using this product:, stop use and ask a dentist or doctor if:, if pregnant or breast-feeding,, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

(in each lozenge)

Benzocaine 6 mg

(in each lozenge)

Menthol 10 mg

(in each lozenge)

Benzocaine 6 mg

(in each lozenge)

Menthol 10 mg

(in each lozenge)

Benzocaine 6 mg

(in each lozenge)

Menthol 10 mg

Purpose

Oral Anesthetic/Analgesic

Oral Anesthetic/Analgesic

Oral Anesthetic/Analgesic

Oral Anesthetic/Analgesic

Oral Anesthetic/Analgesic

Oral Anesthetic/Analgesic

Uses

Temporarily relieves:

  • occasional minor irritation, pain, sore throat and sore mouth

    • Temporarily relieves:

    • occasional minor irritation, pain, sore throat and sore mouth

      • 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.

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.

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.

do not exceed recommended dosage.

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

ask a health care professional before use.

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.

In case of overdose or accidental poisoning, get medical help or contact a Poison Control Center right away.

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.
    • 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.
      • 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 59°F and 86°F (15°C - 30°C).
  • Protect from moisture.
  • Check expiration date before using.
  • Tamper Evident: Do not use if blister package with “Chloraseptic®” name has been disturbed or opened.
    • Store between 59°F and 86°F (15°C - 30°C).
    • Protect from moisture.
    • Check expiration date before using.
    • Tamper Evident: Do not use if blister package with “Chloraseptic®” name has been disturbed or opened.
      • Store between 59°F and 86°F (15°C - 30°C).
      • 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 Red #40, Flavor, Glycerine, Soy Lecithin, Sucrose, Water

Corn Syrup, FD&C Red #40, FD&C Yellow #6, Flavor, Glycerine, Propylene Glycol, Soy Lecithin, Sucrose, Water

Corn Syrup, FD&C Yellow #5, Flavor, Glycerine, Honey, Propylene Glycol, Soy Lecithin, Sucrose, Water

Questions?

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

Drug Facts

Chloraseptic Citrus Lozenges

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

Drug Facts

Chloraseptic Honey Lemon Lozenges

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

Principal Display Panel

Chloraseptic® 
SORE THROAT
18 lozenges | Cherry

Principal Display Panelchloraseptic® Sore Throat 15 Lozenges | Cherry (Chloraseptic Cherry Honey Lemon And Citrus Lozenge 01)

Principal Display Panelchloraseptic® Sore Throat 15 Lozenges | Cherry (Chloraseptic Cherry Honey Lemon And Citrus Lozenge 01)

Chloraseptic® 
SORE THROAT
18 lozenges | Citrus

Principal Display Panelchloraseptic® Sore Throat 18 Lozenges | Citrus (Chloraseptic Cherry Honey Lemon And Citrus Lozenge 02)

Principal Display Panelchloraseptic® Sore Throat 18 Lozenges | Citrus (Chloraseptic Cherry Honey Lemon And Citrus Lozenge 02)

Chloraseptic® 
SORE THROAT
18 lozenges | Honey Lemon with real honey

Principal Display Panelchloraseptic® Sore Throat 18 Lozenges | Honey Lemon With Real Honey (Chloraseptic Cherry Honey Lemon And Citrus Lozenge 03)

Principal Display Panelchloraseptic® Sore Throat 18 Lozenges | Honey Lemon With Real Honey (Chloraseptic Cherry Honey Lemon And Citrus Lozenge 03)

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