CARE ONE SORE THROAT- phenol spray 
American Sales Company

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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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 fever, headache, rash, swelling, nausea, or 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

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

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • apply to the affected area
  • 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
adults and children 12 years of age & olderspray 5 times for each application
children 3 to under 12 years (with adult supervision)spray 3 times for each application
children under 3 years of ageask a doctor or dentist

Other information

store at 20°-25°C (68°-77°F)

Inactive ingredients

FD&C red no. 40, flavor, glycerin, purified water, saccharin sodium

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to the Active Ingredient in Chloraseptic®

FAST RELIEF

SORE THROAT SPRAY

PHENOL/ORAL ANESTHETIC

CHERRY FLAVOR

Fast-Acting, Long Lasting

Relief of Minor Sore Throat and Mouth Pain

Sore Throat Spray Label

Sore Throat Spray Label

CARE ONE SORE THROAT 
phenol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-328
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENOL (PHENOL) PHENOL1.4 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 
GLYCERIN 
WATER 
SACCHARIN SODIUM 
Product Characteristics
ColorRED (clear) Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:41520-328-30177 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35611/19/2003
Labeler - American Sales Company (809183973)

Revised: 07/2009
 
American Sales Company