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  5. Label Information: Phenol

FDA Label for Phenol

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. OTC - DO NOT USE
    6. OTC - ASK DOCTOR
    7. OTC - WHEN USING
    8. OTC - PREGNANCY OR BREAST FEEDING
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. DOSAGE & ADMINISTRATION
    11. STORAGE AND HANDLING
    12. INACTIVE INGREDIENT
    13. HOW SUPPLIED

Phenol Product Label

The following document was submitted to the FDA by the labeler of this product Purinepharma Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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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