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Orasep by Llorens Pharmaceutical International Division

Dosage form: liquid
Ingredients: BENZOCAINE 2mg in 100mL, MENTHOL 0.5mg in 100mL, CETYLPYRIDINIUM CHLORIDE 0.1mg in 100mL
Labeler: Llorens Pharmaceutical International Division
NDC Code: 54859-504

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.

Active Ingredients:

Benzocaine...................... 2%      Anesthetic

Cetylpyridinium Chloride..........0.1% Antiseptic

Menthol.................................0.5% Anesthetic

Purpose

Oral anesthetic

Oral antiseptic

Uses for temporary relief of:

  • Occasional minor sore throat pain and dry scratch throat.
  • Pain due to canker sores. Pain due to minor irritation or injury of the mouth and gums. Pain due to minor dental procedures, minor irritations cause by dentures or orthodontic appliances.

 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 sever, persists for more than2 days, is accompanied or followed by fever, headache, rash, nausea, or vomitings, 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 persist or worsens.

Do not exceed recommended dosage.

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

Keep this and all drugs out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

If pregnant or breast feeding, ask a health professional before use.

Directions: 

  • Adults and children 6 years of age or older: spray into throat or onto affected area with one spray per use. Use up to 4 times daily or as directed by a doctor or dentist
  • Children under 6 years of age: ask a doctor or dentist.

Inactive Ingredients: Artificial and natural flavors, methylparaben, polyoxyl hydrogenated castor oil, propylene glycol, propylparaben, purified water, and sucralose.

Questions or comments? 1-866-595-5598

ORASEP 
benzocaine, menthol, cetylpyridinium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54859-504
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE2 mg  in 100 mL
MENTHOL (MENTHOL) MENTHOL0.5 mg  in 100 mL
CETYLPYRIDINIUM CHLORIDE (CETYLPYRIDINIUM) CETYLPYRIDINIUM CHLORIDE0.1 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CASTOR OIL 
METHYLPARABEN 
PROPYLENE GLYCOL 
PROPYLPARABEN 
WATER 
SUCRALOSE 
Packaging
#Item CodePackage Description
1NDC:54859-504-0130 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35604/01/2010
Labeler - Llorens Pharmaceutical International Division (037342305)

 
Llorens Pharmaceutical International Division

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Medically reviewed on May 15, 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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