SORE THROAT- phenol spray 
We Care Distributor Inc.

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

Active ingredient

Phenol 1.4%

Purpose

Oral anesthetic/analgesic

Uses

Warnings

Sore throat warning: Severe or persistent 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.

When using this product

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

Stop use and ask a doctor or dentist if

  • sore mouth symptoms do not improve in 7 days
  • irritation, pain or redness persists or worsens
  • swelling, rash or fever develops

If pregnant or breast-feeding,

ask doctor before use.

Keep out of reach of children.

In case of overdose or accidental poisoning, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

FD&C red #40, flavor, glycerin, purified water, saccharin sodium

Principal Display Panel

Compare to the Active Ingredient in Chloraseptic

FAST RELIEF

SORE THROAT SPRAY

PHENOL / ORAL ANESTHETIC

CHERRY FLAVOR

Instant-Acting

Relieves Sore Throat

See New Directions

Sore Throat Spray Label Image

SORE THROAT 
phenol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70005-035
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) PHENOL1.4 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
Product Characteristics
ColorRED (clear) Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70005-035-0130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product09/23/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35609/23/2016
Labeler - We Care Distributor Inc. (079832998)
Establishment
NameAddressID/FEIBusiness Operations
PURINE PHARMA LLC019950491manufacture(70005-035)

Revised: 9/2016
Document Id: 35dbe896-ac5e-4810-9597-80f5e284d001
Set id: 15095229-f59d-4855-b38f-a090d661860a
Version: 3
Effective Time: 20160923
 
We Care Distributor Inc.