Chloraseptic Sore Throat Max Spray
FDA Label NDC 67172-937

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 Max (NDC 67172-937). 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, if pregnant or breast-feeding,, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Phenol 1.5%

Glycerin 33%

Purpose

Oral Anesthetic/Analgesic

Demulcent

Uses

for the temporary relief of ■ occasional minor irritation, pain, sore mouth and sore throat ■ minor discomfort and protection of irritated areas in sore mouth and sore throat

Warnings

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.

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 right away.

Directions

Adults and children 3 years of age and older:

  • apply to the affected area (one spray)
  • allow to remain in place for at least 15 seconds, then spit out
  • use every 2 hours or as directed by a doctor or dentist

    • Children under 12 years of age should be supervised by an adult in the use of this product.

    Children under 3 years of age: consult a doctor or dentist.

Other Information

  • store at room temperature
  • check expiration date before using

Inactive Ingredients

FD&C blue no. 1, FD&C red no. 40, flavor, purified water, sodium saccharin, sucralose

Questions?

1-800-552-7932 Chloraseptic.com

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