Pennacaine

Larken Laboratories, Inc.

Pinnacaine Otic Drops

FULL PRESCRIBING INFORMATION

ACTIVE INGREDIENT:

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

in an aqueous base.

Benzocaine, a local anesthetic, is chemically, ethyl p-aminobenzoate, C₉H₁₁NO₂, with a molecular weight of 165.19.

Glycerin, Polyethylene Glycol, Benzethonium Chloride, Purified Water.

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.

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.

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.

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.

Medication should be discontinued if sensitivity or irritation occurs.

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

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.

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

Do not use in infants under 1 year of age.

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.

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.

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.

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

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

Figure 1: 15 mL container label

Figure 2: 15 mL carton