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Orasep by Llorens Pharmaceutical International Division

Medically reviewed on April 3, 2018

Dosage form: liquid
Ingredients: BENZOCAINE 2mL in 100mL, MENTHOL 0.5mL in 100mL, CETYLPYRIDINIUM CHLORIDE 0.1mL 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.

DRUG FACTS

Active Ingredients:

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

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

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



Uses:

  • For temporary relief of ocassional minor sore thoat pain and dry, scratchy throat.
  • For the temporary relief of pain associated with canker sores, minor irritation or injury of the mouth and gums, minor dental procedures, minor irritations caused by dentures or  orthodontic appliances.
  • For temporary relief of sore gums due to teething in infants and children 4 months of age and older.

 Warnings:

  Do not exceed recommended dosage.

Do not use in or near eyes.

  • Ifsore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a physician promptly.
  • If sore mouth symptoms do not improve in 7 days, or if irritation, pain, or redness persists or worsens, see your dentist or physician promptly.
  • Fever and nasal congestion are not symptoms of teething and may indicate the presence of infection. If these symptoms persist, consult your physician.
DO NOT USE: If you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.

Keep 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 Chlidren 6 years and over: Spray Orasep several times to affected area in mouth or lips. Do not use more than 4 times a day. Children under 12 years of age should be supervised in the use of this product. Children under 6 years of age: Consult a physician. For sore gums associated with teething, spray a small amount on finger and rub on the gum after you wash your hands.

As a gargle or mouthwash, Adults and Children 12 years and over, place 1/2 teaspoon (2.5 ml) in 1/2 glass of warm water several times a day. Do not use more than 4 times a day.

In the event of accidental contact with eyes, flush immediately with water and continuously for 10 minutes. Sek immediate medical attention if pain persists.

Other Information: Tamper Evident Feature: Do not use if heat seal under cap is torn, broken or missing. Store at controlled room temperature 15-30 degree celcius ( 59-86 degree fahrenheit).

Inactive Ingredients: Castor oil (Partially Hydrogenated), Methylparaben, Propylene Glycol, Propylparaben, Purified Water, Saccharin Sodium.

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 mL  in 100 mL
MENTHOL (MENTHOL) MENTHOL0.5 mL  in 100 mL
CETYLPYRIDINIUM CHLORIDE (CETYLPYRIDINIUM) CETYLPYRIDINIUM CHLORIDE0.1 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CASTOR OIL 
METHYLPARABEN 
PROPYLENE GLYCOL 
PROPYLPARABEN 
WATER 
SACCHARIN SODIUM 
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 finalpart34604/01/2010
Labeler - Llorens Pharmaceutical International Division (037342305)

 
Llorens Pharmaceutical International Division

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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