SORE THROAT RELIEF- phenol liquid 
Western Family Foods, 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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Drug Facts

Active ingredient

Phenol 1.4%

Purpose

Oral Anesthetic/Analgesic

Uses

temporarily relieves sore throat pain, sore mouth, pain associated with canker sores, minor mouth irritation

Warnings

Sore throat warning: Severe or persistent sore throat or sore throat that occurs with high fever, headache, nausea, and vomiting may be serious. Ask a doctor right away. Do not use more than 2 days or give to children under 3 years of age.

When using this product,

do not use more than directed.

Stop use and ask a doctor if

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

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

  • apply to the affected area
  • use every 2 hours
  • allow to remain in place for at least 15 seconds, then spit out
 age dose 
  adults and children 12 years and over  for each application, spray 5 times 
  children 3 to 11 years  should be supervised in use of this product for each application, spray 3 times
  children under 3 years  ask a doctor or dentist

Other information

  • store at 20º-25ºC (68º-77ºF). Do not refrigerate.

Inactive ingredients

D&C green #5, D&C yellow #10, FD&C green #3, glycerin, menthol, purified water, saccharin sodium

Questions or comments?

Call 1-503-639-6300 Monday-Friday 8AM-4PM PST

Principal Display Panel

Soothing Menthol Flavor

Sore Throat Relief

Phenol/Oral Anesthetic Spray

Instant Acting

Relieves Sore Throat

Fast Relief!

Alcohol Free

Aspirin Free

Sugar Free

Compare to Chloraseptic® Active Ingredient*

*This product is not manufactured or distributed by Prestige Brands, Inc., owner of the registered trademark Chloraseptic®.

TAMPER EVIDENT: DO NOT USE IF IMPRINTED WRAP AROUND THE CAP IS BROKEN OR TORN.

Proudly Distributed by Western Family Foods, Inc.

P.O Box 4057 Portland, OR 97208 USA

www.westernfamily.com

Package Label

Phenol 1.4%

Western Famly Sore Throat Relief Spray

 

SORE THROAT RELIEF 
phenol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55312-377
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
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
GLYCERIN (UNII: PDC6A3C0OX)  
MENTHOL (UNII: L7T10EIP3A)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
Product Characteristics
Color    Score    
ShapeSize
FlavorMENTHOLImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55312-377-06177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/30/201412/31/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35606/30/201412/31/2019
Labeler - Western Family Foods, Inc. (192166072)

Revised: 12/2018
Document Id: 175b0923-6b9d-4b05-b8c7-1038bdbb545d
Set id: 5d40f113-a071-4c25-8b6a-05d5c6f29282
Version: 3
Effective Time: 20181228
 
Western Family Foods, Inc.