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Sore Throat by Safeway, Inc.

Dosage form: spray
Ingredients: PHENOL 1.4g in 100mL
Labeler: Safeway, Inc.
NDC Code: 21130-376

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.

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 accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a 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.

Stop use and ask a dentist or doctor if
  • swelling, rash or fever develops
  • irritation, pain or redness persists or worsens
  • sore mouth symptoms do not improve in 7 days

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
  • adults and children 6 years of age and older
    • apply to affected area (one spray)
    • allow to remain in place for at least 15 seconds, then spit out 
    • use every 2 hours as directed by a doctor or dentist
  • children under 12 years of age should be supervised in the used in this product
  • children under 6 years of age, consult a doctor or dentist

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

Inactive ingredients

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

Questions or comments?

Call 1-888-723-3929 Monday-Friday 7AM-6PM PST

Principal Display Panel

Sore Throat Spray

PHENOL 1.4 %

Oral Anesthetic / Analgesic

Cherry flavor

  • Alcohol 0.10%
  • Aspirin free
  • Sugar free

FL OZ (mL)

COMPARE TO Chloraseptic® active ingredient*

*This product is not manufactured or distributed by Prestige Brands Inc., distributor of Chloraseptic®.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND CAP IS BROKEN OR MISSING.

DISTRIBUTED BY

BETTER LIVING BRAND LLC

P.O. BOX 99, PLEASANTON, CA 94566-0009

Package Label

Signature Care Sore Throat Spray Cherry

SORE THROAT 
phenol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-376
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENOL (PHENOL) PHENOL1.4 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL 
FD&C RED NO. 40 
GLYCERIN 
WATER 
SACCHARIN SODIUM 
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:21130-376-06177 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35611/30/2014
Labeler - Safeway, Inc. (009137209)

 
Safeway, Inc.

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Medically reviewed on Jul 30, 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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