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NDC 63102-0106-01 ACTISEP 2; .1; .5 g/100mL; g/100mL; g/100mL Details

ACTISEP 2; .1; .5 g/100mL; g/100mL; g/100mL

ACTISEP is a TOPICAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Actipharma, Inc. The primary component is BENZOCAINE; CETYLPYRIDINIUM CHLORIDE; MENTHOL, UNSPECIFIED FORM.

Product Information

NDC	63102-0106
Product ID	63102-106_6547c2a3-e3e9-4284-811a-a04956d7dcbd
Associated GPIs	88359903242020
GCN Sequence Number	076283
GCN Sequence Number Description	benzocaine/menth/cetylpyrd Cl SOLUTION 2-0.5-0.1% MUCOUS MEM
HIC3	H0A
HIC3 Description	LOCAL ANESTHETICS
GCN	41695
HICL Sequence Number	011964
HICL Sequence Number Description	BENZOCAINE/MENTHOL/CETYLPYRIDINIUM CHLORIDE
Brand/Generic	Brand
Proprietary Name	ACTISEP
Proprietary Name Suffix	n/a
Non-Proprietary Name	BENZOCAINE, MENTHOL, CETYLPYRIDINIUM CHLORIDE
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	TOPICAL
Active Ingredient Strength	2; .1; .5
Active Ingredient Units	g/100mL; g/100mL; g/100mL
Substance Name	BENZOCAINE; CETYLPYRIDINIUM CHLORIDE; MENTHOL, UNSPECIFIED FORM
Labeler Name	Actipharma, Inc
Pharmaceutical Class	Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part356
Listing Certified Through	2024-12-31

Package

Package Images

NDC 63102-0106-01 (63102010601)

Pricing Information	N/A
NDC Package Code	63102-106-01
Billing NDC	63102010601
Package	30 mL in 1 BOTTLE, PLASTIC (63102-106-01)
Marketing Start Date	2015-12-28
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 092c246f-db0e-4250-8245-a6799e793026 Details

Drug Facts

Active ingredients

Benzocaine .............................2%

Menthol ................................0.5%

Cetylpyridinium Chloride ........0.1%

Purposes

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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

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

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

Labeler - Actipharma, Inc (079340948)

Revised: 12/2018

Document Id: 6547c2a3-e3e9-4284-811a-a04956d7dcbd

Set id: 092c246f-db0e-4250-8245-a6799e793026

Version: 2

Effective Time: 20181205