Skip to Content

← See all ACTISEP brands

ACTISEP by Actipharma, Inc

Medically reviewed on January 18, 2018

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.

ACTISEP® SPRAY

Drug Facts

Active ingredients

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

Purpose

Oral Anesthetic
Oral Anesthetic
Oral Antiseptic

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

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

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.

Packaging

ACTISEP 
benzocaine, menthol, cetylpyridinium chloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63102-107
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE2 g  in 100 mL
MENTHOL, UNSPECIFIED FORM (MENTHOL) MENTHOL, UNSPECIFIED FORM0.5 g  in 100 mL
CETYLPYRIDINIUM CHLORIDE (CETYLPYRIDINIUM) CETYLPYRIDINIUM CHLORIDE0.1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CASTOR OIL 
METHYLPARABEN 
PROPYLPARABEN 
PROPYLENE GLYCOL 
WATER 
SUCRALOSE 
Product Characteristics
Color    Score    
ShapeSize
FlavorMENTHOLImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:63102-107-0130 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35612/28/2015
Labeler - Actipharma, Inc (079340948)

 
Actipharma, Inc

← See all ACTISEP brands

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.

Hide