ACTISEP- benzocaine, menthol, cetylpyridinium chloride spray 
Actipharma, Inc

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.

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ACTISEP® SPRAY

Drug Facts

Active ingredients

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

Purposes

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.

Warnings:

Methemoglobinemia warning:Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:

Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other “caine” anesthetics.If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, or if irritation, pain, or redness persist or worsens, see your dentist or doctor promptly.

Do not exceed recommended dosage.

Do not use

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.

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

Directions:


adults and Children 2 years of age or older:

spray Actisep several times to affected area in mouth or lips. Do not use more than 4 times a day.

children between 2 and 12 years of ageshould be supervised in the use of this product.
children under 2 years of age:do not use

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

Antisepspray

ACTISEP 
benzocaine, menthol, cetylpyridinium chloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63102-107
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE2 g  in 100 mL
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM0.5 g  in 100 mL
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE0.1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CASTOR OIL (UNII: D5340Y2I9G)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
Color    Score    
ShapeSize
FlavorMENTHOLImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63102-107-0130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product12/28/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35612/28/2015
Labeler - Actipharma, Inc (079340948)

Revised: 12/2018
Document Id: c3b0081c-16a9-48ab-b91f-d1d1eb8d6f5d
Set id: d76c26fe-f970-4f4c-8e4a-4db8db3debb0
Version: 2
Effective Time: 20181211
 
Actipharma, Inc