PHENOL- sore throat spray spray 
PURINEPHARMA LLC

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.

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SORE THROAT SPRAY

Active Ingredient:
Phenol 1.4%

Purpose: Oral Anesthetic/ Analgesic

Uses

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.

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:

Other information

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

Medpurine Container Label
PHENOL 
sore throat spray spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58599-008
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) PHENOL1.4 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
CHERRY (UNII: BUC5I9595W)  
Product Characteristics
ColorRED (Red) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58599-008-0130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
2NDC:58599-008-06177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
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/FEIBusiness Operations
PURINEPHARMA LLC019950491MANUFACTURE(58599-008)

Revised: 6/2015
Document Id: 5b36529b-628d-4eb6-858e-634e632a9787
Set id: 5b36529b-628d-4eb6-858e-634e632a9787
Version: 1
Effective Time: 20150615
 
PURINEPHARMA LLC