Phenol
FDA Label NDC 58599-008

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Purinepharma Llc for the product Phenol (NDC 58599-008). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - when using, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredient:
Phenol 1.4%

Otc - Purpose

Purpose: Oral Anesthetic/ Analgesic

Indications & Usage

Uses

  • For the temporary relief of occasional minor throat:
    • Irritation
    • Pain
    • Sore Mouth
    • Sore Throat

Warnings

Warnings

Sore Throat Warnings:
Severe and persisttent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by a doctor.

Otc - Do Not Use

  • do not exceed recommended dose
  • do not use for more than 2 days. Use only aas directed.
  • use of this container by more than one person may spread infection.

Otc - Ask Doctor

Stop use and ask doctor or dentist if sore throat symptoms do not improve in 7 days Irritation, pain or redness persists or worsens. Swelling, rash or fever develops.

Otc - When Using

  • do not exceed recommended dose
  • do not use for more than 2 days. Use only aas directed.
  • use of this container by more than one person may spread infection.

Otc - Pregnancy Or Breast Feeding

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of overdose or accidental poisioning, get medical help or contact a Poison Control Center right away.

Dosage & Administration

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 on the nozzle with index finger without tiltting head. Fully depress pump all the way down with a firm even stroke. Wipe nizzle dry.

Storage And Handling

Other information

  • Store at room temperature
  • Temper Evident: Do not use if printed neck band is broken or missing
  • Check expiration date before using

Inactive Ingredient

Inactive ingredients are: Sodium Saccharin, Glycerin, Purified water, FD&C red# 40, Cherry Flavour.

How Supplied

Manufactured in USA by
Purinepharma LLC

5 County Route 42
Massena, NY 13662
A MEDIBEST Brands Company

Questions: www.purinepharma.com
Tel: 1-315-705-4030
NDC: 58599-008-06

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