Phenol Spray
FDA Label NDC 83324-031

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Marketing Association Inc. for the product Phenol (NDC 83324-031). 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 ingredient                         purpose, uses, warnings, directions, other information, inactive ingredients, principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient                         Purpose

Phenol 1.4%............. Oral Anesthetic/Analgesic

Uses

  • For temporary relief of occasional minor throat irritation, pain, sore mouth, sore throat.

Warnings

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 in the use of this product. Children under 3 years of age, consult a doctor or dentist
  • Before using the first time, remove the protective neck band and dust cap from the tip. To spray hold bottle straight up and press the
    nozzle with index finger without tilting head. Fully depress pump all the way down with a firm, even stroke. Wipe nozzle dry.

Other Information

  • Store at room temperature

Inactive Ingredients

cherry flavor, FD&C Red #40, glycerin, purified water, sodium saccharin.

Principal Display Panel

NDC-83324-031-06

Containerlabel (Containerlabel)

Containerlabel (Containerlabel)

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