Orasep

Llorens Pharmaceutical International Division

DRUG FACTS

FULL PRESCRIBING INFORMATION

Active ingredient

Active Ingredients:

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

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

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

Purpose

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.

• If sore 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.

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: Use 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, use 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.

Uses

In the event of accidental contact with eyes, flush immediately with water and continuosly 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 arenheit).

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

Questions or comments? 1-866-595-5598