PENNACAINE- benzocaine solution/ drops
Larken Laboratories, Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Pinnacaine Otic Drops

DESCRIPTION

ACTIVE INGREDIENT:

Benzocaine.....................20%

in an aqueous base.

Benzocaine, a local anesthetic, is chemically, ethyl p-aminobenzoate, C 9H 11NO 2, with a molecular weight of 165.19.

INACTIVE INGREDIENTS

Glycerin, Polyethylene Glycol, Benzethonium Chloride, Purified Water.

CLINICAL PHARMACOLOGY

Benzocaine acts by blocking conduction in nerve fibers as a result of decreased nerve cell membrane permeability to sodium ions or competition with calcium ions for membrane binding sites.

INDICATIONS AND USAGE

Pinnacaine Otic Drops may be used as a topical anesthetic in the external auditory canal to relieve ear pain. It may be used in the treatment of acute otitis media, acute swimmer’s ear and other forms of otitis externa.

CONTRAINDICATIONS

Pinnacaine Otic Drops is contraindicated in patients sensitive to benzocaine. This medication should not be applied in the external auditory canal if there is a perforated eardrum or ear discharge.

WARNINGS

KEEP OUT OF REACH OF CHILDREN. NOT FOR OPHTHALMIC OR ORAL USE.

Use of anesthetic ear drops indiscriminately may mask symptoms of infection of the middle ear.

PRECAUTIONS

General

Medication should be discontinued if sensitivity or irritation occurs.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long term studies of animals or humans to evaluate the carcinogenic and mutagenic potential or the effect on fertility have not been conducted.

Pregnancy

Pregnancy Category C:

There are no adequate and well-controlled studies in pregnant women. This product should only be given to pregnant women if clearly needed.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Caution should be used when administered to nursing women.

Pediatric Use

Do not use in infants under 1 year of age.

ADVERSE REACTIONS

Benzocaine can cause a hypersensitivity reaction consisting of rash, urticaria and edema. Individuals frequently exposed to ester-type local anesthetics can develop contact dermatitis characterized by erythema and pruritus. Rarely, benzocaine may induce methemoglobinemia causing respiratory distress and cyanosis which can be treated by intravenous methylene blue.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at

1-800-FDA-1088.

OVERDOSAGE

Effects of benzocaine overdosage may include yawning, restlessness, excitement, nausea and vomiting. Treatment is symptomatic. Please call your local Poison Control Center or your doctor if you suspect an overdosage of this product.

DOSAGE AND ADMINISTRATION

Administer 4-5 drops of Pinnacaine Otic Drops in the external ear canal and then insert a cotton pledget into the meatus. Can be repeated every 1 to 2 hours, if necessary.

HOW SUPPLIED

Pinnacaine Otic Drops, NDC# 68047-057-15, is supplied in a 15 mL amber glass bottle with dropper and package insert.

Storage and Handling

Store at 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]. Store in a tight, light-resistant Container. [See USP.} Keep bottle tightly closed.

Distributed by:

Larken Laboratories, Inc.

Canton, MS 39046

Iss. 07/11

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Figure 1: 15 mL container label

Figure 2: 15 mL carton

PENNACAINE
benzocaine solution/ drops

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:68047-057
Route of Administration	AURICULAR (OTIC)	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	200 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
BENZETHONIUM CHLORIDE (UNII: PH41D05744)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description
Packaging
1	NDC:68047-057-15	1 in 1 CARTON
1		15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		08/08/2011	11/10/2015

Labeler - Larken Laboratories, Inc. (149484540)

Name	Address	ID/FEI	Business Operations
Establishment
Sonar Products, Inc.		104283945	manufacture(68047-057)

Revised: 11/2015

Document Id: 24374b99-d342-454b-e054-00144ff8d46c

Set id: e22a729e-ea74-407c-980d-0a1c15352419

Version: 3

Effective Time: 20151110

Larken Laboratories, Inc.