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  5. Label Information: Actisep

FDA Label for Actisep

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. ACTIVE INGREDIENTS
    3. PURPOSE
    4. USES:
    5. WARNINGS:
    6. DIRECTIONS:
    7. INACTIVE INGREDIENTS:
    8. OTHER INFORMATION:
    9. QUESTIONS OR COMMENTS?
    10. PACKAGING

Actisep Product Label

The following document was submitted to the FDA by the labeler of this product Actipharma, Inc. 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.

Drug Facts




Active Ingredients



Benzocaine .........................2%
Menthol .............................0.5%
Cetylpyridinium Chloride .....0.1%


Purpose



Oral Anesthetic
Oral Anesthetic
Oral Antiseptic


Uses:



• For temporary relief of occasional minor sore throat 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 the 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.

    • DO NOT USE: If you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other “caine” anesthetics.

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

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


Directions:




Adults and Children 6 years and over:

Spray Actisep 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 gums after you wash your hands. -
As a gargle or mouthwash, Adults and Children 12 years and over, place ½ teaspoon (2.5 mL) in ½ glass of warm water several times a day. Do not use more than 4 times a day. -


Inactive Ingredients:



Castor oil, methylparaben, propylparaben, propylene glycol, purified water, sucralose.


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°C (59-86°F).


Questions Or Comments?



(787) 608-0882


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