Chloraseptic Lozenge
FDA Label NDC 67172-021

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 (NDC 67172-021). 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 (in each lozenge), purpose, uses, warnings, do not use, when using this product, stop use and ask a dentist or doctor if:, if pregnant or breast-feeding,, 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

Menthol 10 mg

Purpose

Oral pain reliever

Oral pain reliever

Uses

Temporarily relieves occasional minor irritation, pain, sore throat and sore mouth.

Warnings

Methemoglobinemia warning:

Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:

  • pale, gray, or blue colored skin (cyanosis)
  • headache
  • rapid heart rate
  • shortness of breath
  • dizziness or lightheadedness
  • fatigue or lack of energy

    • 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

  • Store between 15○C - 30○C (59○F - 86○F)
  • Protect from moisture
  • Check expiration date before using

Inactive Ingredients

corn syrup, FD&C red no. 40, flavor, glycerin, soy lecithin, sucrose, water

Questions?

1-800-552-7932 Chloraseptic.com

Principal Display Panel

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