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Phenol

Dosage form: spray
Ingredients: PHENOL 1.4mg in 1mL
Labeler: PURINEPHARMA LLC
NDC Code: 58599-008

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

SORE THROAT SPRAY

Active Ingredient:
Phenol 1.4%

Purpose: Oral Anesthetic/ Analgesic

Uses

  • For the temporary relief of occasional minor throat:
    1. Irritation
    2. Pain
    3. Sore Mouth
    4. Sore Throat

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.

  • 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.

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.

  • 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.

Keep out of reach of children. In case of overdose or accidental poisioning, 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 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.

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

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

PHENOL 
sore throat spray spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58599-008
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENOL (PHENOL) PHENOL1.4 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SACCHARIN SODIUM 
GLYCERIN 
WATER 
FD&C RED NO. 40 
CHERRY 
Product Characteristics
ColorRED (Red) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:58599-008-0130 mL in 1 BOTTLE, SPRAY
2NDC:58599-008-06177 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35603/01/2015
Labeler - PURINEPHARMA LLC (019950491)
Registrant - PURINEPHARMA LLC (019950491)
Establishment
NameAddressID/FEIOperations
PURINEPHARMA LLC019950491MANUFACTURE(58599-008)

 
PURINEPHARMA LLC

Medically reviewed on Jun 15, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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