ACTISEP- benzocaine, menthol, cetylpyridinium chloride solution

ACTISEP by

Drug Labeling and Warnings

ACTISEP by is a Otc medication manufactured, distributed, or labeled by Actipharma, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

• pale, gray, or blue colored skin (cyanosis)
• headache
• rapid heart rate
• shortness of breath
• dizziness or lightheadedness
• fatigue or lack of energy

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

• in or near eyes
• for teething
• in children under 2 years of age

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 age: should 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

SPL UNCLASSIFIED SECTION

Contains the same active ingredients as Orasep® Solution*

ANTISEPTIC ANESTHETIC

Alcohol Free

Manufactured in the USA for 

ActiPharma, Inc.
Dorado, PR 00646

*Orasep® Solution is a registered trademark of Llorens Pharmaceutical Corp.
This product is not manufactured, distributed or marketed by Llorens Pharmaceutical Corp.

Packaging

INGREDIENTS AND APPEARANCE

ACTISEP 
benzocaine, menthol, cetylpyridinium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63102-106
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	2 g  in 100 mL
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	0.5 g  in 100 mL
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3)	CETYLPYRIDINIUM CHLORIDE	0.1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CASTOR OIL (UNII: D5340Y2I9G)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color		Score
Shape		Size
Flavor	MENTHOL	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63102-106-01	30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/28/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	12/28/2015

Labeler - Actipharma, Inc (079340948)