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Cepacol Dual Relief

Dosage form: spray
Ingredients: BENZOCAINE 0.0508g in 1mL, GLYCERIN 0.335g in 1mL
Labeler: Combe Incorporated
NDC code: 11509-0054

Cepacol Dual Relief

Cēpacol® Dual Relief Spray

Active Ingredients

Benzocaine 5.0%                              

Purpose

Oral anesthetic

Active Ingredients

Glycerin 33.0%                              

Purpose

Oral demulcent

Uses

for the temporary relief of:

  • occasional minor irritation, pain, sore mouth and sore throat
  • pain due to canker sores
  • pain due to minor irritation or injury of the mouth and gums
  • minor discomfort and protection of irritated areas in sore mouth and sore throat

Warnings

Allergy alert: Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or any other ‘caine’ anesthetics.

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea or vomiting, consult a doctor promptly.

Stop use and ask a doctor if 

sore mouth symptoms do not improve in 7 days, or if irritation, pain or redness persists or worsens.

If pregnant or breast feeding

ask a health professional before use.

Keep this and all drugs out of reach of children

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

Do not exceed recommended dosage.

Flammable. Do not use near fire, flame or heat.

When using this product

do not get into eyes. If contact occurs, rinse eyes thoroughly with water. If irritation persists, consult a doctor.

Directions
  • shake well before use.
  • adults and children 6 years of age or older: spray into throat or onto affected area with only ONE spray per use. Use up to 4 times daily or as directed by a doctor or dentist.
  • children 6 to 12 years of age should be supervised in the use of this product.
  • children under 6 years of age: do not use.

Other information   
  • store at room temperature (68-77°F) (20-25°C)   
  • do not freeze

Inactive ingredients  

deionized water, flavor, neotame, PEG-40 hydrogenated castor oil, potassium acesulfame, PVP, SD alcohol 38B

Principal Display Panel

Cherry

Directable Spray

TARGETS the PAIN

Cēpacol®

Dual Relief Spray

Sore Throat + Coating

Oral Anesthetic and Demulcent

Just One Shot

  • Instantly numbs pain
  • Coats and soothes

100 Doses

0.75 FL. OZ. (22.2 ml)

CEPACOL DUAL RELIEF 
benzocaine and glycerin spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11509-0054
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE0.0508 g  in 1 mL
GLYCERIN (GLYCERIN) GLYCERIN0.335 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
NEOTAME 
POLYOXYL 40 HYDROGENATED CASTOR OIL 
ACESULFAME POTASSIUM 
POVIDONE K30 
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:11509-0054-11 BOTTLE, PUMP (1 BOTTLE) in 1 CARTON
122.2 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35609/01/2007
Labeler - Combe Incorporated (002406502)

Revised: 12/2009
 
Combe Incorporated

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.