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  5. Label Information: Orasep

FDA Label for Orasep

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. WARNINGS
    4. OTC - DO NOT USE
    5. OTC - KEEP OUT OF REACH OF CHILDREN
    6. OTC - PREGNANCY OR BREAST FEEDING
    7. DOSAGE & ADMINISTRATION
    8. INDICATIONS & USAGE
    9. INACTIVE INGREDIENT
    10. OTC - QUESTIONS
    11. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Orasep Product Label

The following document was submitted to the FDA by the labeler of this product Llorens Pharmaceutical International Division. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Active Ingredients:

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

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

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




Otc - 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



 Warnings:

  Do not exceed recommended dosage.


Otc - Do Not Use



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.

Otc - Keep Out Of Reach Of Children



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


Otc - Pregnancy Or Breast Feeding



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


Dosage & Administration



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.


Indications & Usage



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 Ingredient



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


Otc - Questions



Questions or comments? 1-866-595-5598


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