PHENOL- sore throat spray spray

Phenol by

Drug Labeling and Warnings

Phenol by is a Otc medication manufactured, distributed, or labeled by PURINEPHARMA LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient:
Phenol 1.4%

PURPOSE

Purpose: Oral Anesthetic/ Analgesic

INDICATIONS & USAGE

Uses

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

• 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.

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.

PREGNANCY OR BREAST FEEDING

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PHENOL 
sore throat spray spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58599-008
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV)	PHENOL	1.4 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
FD&C RED NO. 40 (UNII: WZB9127XOA)
CHERRY (UNII: BUC5I9595W)

Product Characteristics
Color	RED (Red)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58599-008-01	30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
2	NDC: 58599-008-06	177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	03/01/2015

Labeler - PURINEPHARMA LLC (019950491)

Registrant - PURINEPHARMA LLC (019950491)

Establishment
Name	Address	ID/FEI	Business Operations
PURINEPHARMA LLC		019950491	MANUFACTURE(58599-008)