ACTISEP by Actipharma, Inc
Dosage form: spray
Ingredients: BENZOCAINE 2g in 100mL, MENTHOL, UNSPECIFIED FORM 0.5g in 100mL, CETYLPYRIDINIUM CHLORIDE 0.1g in 100mL
Labeler: Actipharma, Inc
NDC Code: 63102-107
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.
Cetylpyridinium Chloride .....0.1%
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
• 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.
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.
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.||-|
Castor oil, methylparaben, propylparaben, propylene glycol, purified water, sucralose.
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).
Contains the same active ingredients as Orasep® Spray*
ANTISEPTIC • ANESTHETIC Alcohol Free
Manufactured in the USA for ActiPharma, Inc.
Dorado, PR 00646
*Orasep® Spray is a registered trademark of Llorens Pharmaceutical Corp.
This product is not manufactured, distributed or marketed by Llorens Pharmaceutical Corp.
benzocaine, menthol, cetylpyridinium chloride spray
|Labeler - Actipharma, Inc (079340948)|
Medically reviewed on Jan 18, 2018