NDC 54868-4928 Ciprodex

NDC Product Code 54868-4928

NDC CODE: 54868-4928

Proprietary Name: Ciprodex What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used to treat bacterial ear infections. It is used to treat middle ear infections in children with ear tubes, as well as outer ear infections (also known as swimmer's ear) in children and adults. This medication contains a combination of ciprofloxacin (a quinolone-type antibiotic) and dexamethasone (an anti-inflammatory corticosteroid). This ear drop works by stopping the growth of bacteria and reducing ear swelling and discomfort. This medication treats only bacterial ear infections. It will not work for other types of ear infections. Unnecessary use or overuse of any antibiotic can lead to its decreased effectiveness.

NDC Code Structure

  • 54868 - Physicians Total Care, Inc.

NDC 54868-4928-0

Package Description: 7.5 mL in 1 BOTTLE, PLASTIC

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Ciprodex with NDC 54868-4928 is a product labeled by Physicians Total Care, Inc.. The product's dosage form is and is administered via form. The RxNorm Crosswalk for this NDC code indicates multiple RxCUI concepts are associated to this product: 403908 and 404630.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • BORIC ACID (UNII: R57ZHV85D4)
  • ACETIC ACID (UNII: Q40Q9N063P)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • TYLOXAPOL (UNII: Y27PUL9H56)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Physicians Total Care, Inc.
Labeler Code: 54868
Start Marketing Date: 09-21-2004 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2017 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: I - INACTIVATED, the listing data was inactivated by the FDA. What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

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Information for Patients

Ciprofloxacin and Dexamethasone Otic

Ciprofloxacin and Dexamethasone Otic is pronounced as (sip roe flox' a sin) (dex a meth' a sone)

Why is ciprofloxacin and dexamethasone otic medication prescribed?
Ciprofloxacin and dexamethasone otic is used to treat outer ear infections in adults and children and acute (suddenly occurring) middle ear infections in children with ea...
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Ciprodex Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Description

CIPRODEX® (ciprofloxacin 0.3% and dexamethasone 0.1%) Sterile
Otic Suspension contains the synthetic broad-spectrum antibacterial agent,
ciprofloxacin hydrochloride, combined with the anti-inflammatory corticosteroid,
dexamethasone, in a sterile, preserved suspension for otic use. Each mL of
CIPRODEX® Otic contains ciprofloxacin hydrochloride (equivalent to 3 mg
ciprofloxacin base), 1 mg dexamethasone, and 0.1 mg benzalkonium chloride as a
preservative. The inactive ingredients are boric acid, sodium chloride,
hydroxyethyl cellulose, tyloxapol, acetic acid, sodium acetate, edetate
disodium, and purified water. Sodium hydroxide or hydrochloric acid may be added
for adjustment of pH.Ciprofloxacin, a fluoroquinolone is available as the monohydrochloride
monohydrate salt of
1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic
acid. The empirical formula is C17H18FN3O3·HCl·H2O and the structural formula
is:Dexamethasone,
9-fluoro-11(beta),17,21-trihydroxy-16(alpha)-methylpregna-1,4-diene-3,20-dione,
is an anti-inflammatory corticosteroid. The empirical formula is C22H29FO5 and the
structural formula is:

Clinical Pharmacology

PharmacokineticsFollowing a single bilateral 4-drop (total dose = 0.28 mL, 0.84
mg ciprofloxacin, 0.28 mg dexamethasone) topical otic dose of CIPRODEX® Otic to
pediatric patients after tympanostomy tube insertion, measurable plasma
concentrations of ciprofloxacin and dexamethasone were observed at 6 hours
following administration in 2 of 9 patients and 5 of 9 patients,
respectively.Mean ± SD peak plasma concentrations of ciprofloxacin were 1.39 ± 0.880 ng/mL
(n=9). Peak plasma concentrations ranged from 0.543 ng/mL to 3.45 ng/mL and were
on average approximately 0.1% of peak plasma concentrations achieved with an
oral dose of 250-mg [1]. Peak plasma concentrations of
ciprofloxacin were observed within 15 minutes to 2 hours post dose
application.Mean ± SD peak plasma concentrations of dexamethasone were 1.14 ± 1.54 ng/mL
(n=9). Peak plasma concentrations ranged from 0.135 ng/mL to 5.10 ng/mL and were
on average approximately 14% of peak concentrations reported in the literature
following an oral 0.5-mg tablet dose [2]. Peak plasma
concentrations of dexamethasone were observed within 15 minutes to 2 hours post
dose application.Dexamethasone has been added to aid in the resolution of the inflammatory
response accompanying bacterial infection (such as otorrhea in pediatric
patients with AOM with tympanostomy tubes).MicrobiologyCiprofloxacin has in vitro activity
against a wide range of gram-positive and gram-negative microorganisms. The
bactericidal action of ciprofloxacin results from interference with the enzyme,
DNA gyrase, which is needed for the synthesis of bacterial DNA. Cross-resistance
has been observed between ciprofloxacin and other fluoroquinolones. There is
generally no cross-resistance between ciprofloxacin and other classes of
antibacterial agents such as beta-lactams or aminoglycosides.Ciprofloxacin has been shown to be active against most isolates of the
following microorganisms, both in vitro and
clinically in otic infections as described in the INDICATIONS AND USAGE section.Aerobic and facultative gram-positive microorganismsStaphylococcus aureusStreptococcus pneumoniaeAerobic and facultative gram-negative microorganismsHaemophilus influenzaeMoraxella catarrhalisPseudomonas
aeruginosa

Indications And Usage

CIPRODEX® Otic is indicated for the treatment of infections
caused by susceptible isolates of the designated microorganisms in the specific
conditions listed below:Acute Otitis Media in pediatric patients (age 6
months and older) with tympanostomy tubes due to Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus
influenzae, Moraxella catarrhalis, and Pseudomonas aeruginosa.Acute Otitis Externa in pediatric (age 6 months and
older), adult and elderly patients due to Staphylococcus aureus and Pseudomonas aeruginosa.

Contraindications

CIPRODEX® Otic is contraindicated in patients with a history
of hypersensitivity to ciprofloxacin, to other
quinolones, or to any of the components in this
medication. Use of this product is contraindicated in
viral infections of the external canal including herpes
simplex infections.

Warnings

FOR OTIC USE ONLY(This product is
not approved for ophthalmic use.)NOT FOR INJECTIONCIPRODEX® Otic should be
discontinued at the first appearance of a skin rash or any other sign of
hypersensitivity. Serious and occasionally fatal hypersensitivity (anaphylactic)
reactions, some following the first dose, have been reported in patients
receiving systemic quinolones. Serious acute hypersensitivity reactions may
require immediate emergency treatment.

Precautions

GeneralAs with other antibacterial preparations, use of this product may
result in overgrowth of nonsusceptible organisms, including yeast and fungi. If
the infection is not improved after one week of treatment, cultures should be
obtained to guide further treatment. If otorrhea persists after a full course of
therapy, or if two or more episodes of otorrhea occur within six months, further
evaluation is recommended to exclude an underlying condition such as
cholesteatoma, foreign body, or a tumor.The systemic administration of quinolones, including ciprofloxacin at doses
much higher than given or absorbed by the otic route, has led to lesions or
erosions of the cartilage in weight-bearing joints and other signs of
arthropathy in immature animals of various species.Guinea pigs dosed in the middle ear with CIPRODEX® Otic for one month
exhibited no drug-related structural or functional changes of the cochlear hair
cells and no lesions in the ossicles. CIPRODEX® Otic was also shown to lack
dermal sensitizing potential in the guinea pig when tested according to the
method of Buehler.No signs of local irritation were found when CIPRODEX® Otic was applied
topically in the rabbit eye.Information for PatientsFor otic use only. (This product is not approved for use in the
eye.) Warm the bottle in your hand for one to two minutes prior to use and shake
well immediately before using.Avoid contaminating the tip with material from
the ear, fingers, or other sources.Protect from light.If rash or
allergic reaction occurs, discontinue use immediately and contact your
physician.It is very important to use the ear drops for as long as the
doctor has instructed, even if the symptoms
improve.Discard unused portion after therapy is completed.Acute Otitis Media in pediatric patients with tympanostomy
tubes Prior to administration of CIPRODEX® Otic in patients (6 months and
older) with acute otitis media through tympanostomy tubes, the suspension should
be warmed by holding the bottle in the hand for one or two minutes to avoid
dizziness which may result from the instillation of a cold suspension. The
patient should lie with the affected ear upward, and then the drops should be
instilled. The tragus should then be pumped 5 times by pushing inward to
facilitate penetration of the drops into the middle ear. This position should be
maintained for 60 seconds. Repeat, if necessary, for the opposite ear (see DOSAGE AND ADMINISTRATION).Acute Otitis ExternaPrior to administration of
CIPRODEX® Otic in patients with acute otitis externa, the suspension should be
warmed by holding the bottle in the hand for one or two minutes to avoid
dizziness which may result from the instillation of a cold suspension. The
patient should lie with the affected ear upward, and then the drops should be
instilled. This position should be maintained for 60 seconds to facilitate
penetration of the drops into the ear canal. Repeat, if necessary, for the
opposite ear (see DOSAGE AND
ADMINISTRATION).Drug InteractionsSpecific drug interaction studies have not been conducted with
CIPRODEX® Otic.Carcinogenesis, Mutagenesis, Impairment of
FertilityLong-term carcinogenicity studies in mice and rats have been
completed for ciprofloxacin. After daily oral doses of 750 mg/kg (mice) and 250
mg/kg (rats) were administered for up to 2 years, there was no evidence that
ciprofloxacin had any carcinogenic or tumorigenic effects in these species. No
long term studies of CIPRODEX® Otic have been performed to evaluate carcinogenic
potential.Eight in vitro mutagenicity tests have been
conducted with ciprofloxacin, and the test results are listed below:Salmonella/Microsome Test (Negative)E. coli DNA Repair Assay (Negative)Mouse Lymphoma Cell
Forward Mutation Assay (Positive)Chinese Hamster V79
Cell HGPRT Test (Negative)Syrian Hamster Embryo Cell Transformation Assay
(Negative)Saccharomyces cerevisiae Point Mutation
Assay (Negative)Saccharomyces cerevisiae Mitotic
Crossover and Gene Conversion Assay (Negative)Rat Hepatocyte DNA Repair
Assay (Positive)Thus, 2 of the 8 tests were positive, but results of the
following 3 in vivo test systems gave negative
results:Rat Hepatocyte DNA Repair AssayMicronucleus Test
(Mice)Dominant Lethal Test (Mice)Fertility studies performed in rats at oral doses of ciprofloxacin up to 100
mg/kg/day revealed no evidence of impairment. This would be over 100 times the
maximum recommended clinical dose of ototopical ciprofloxacin based upon body
surface area, assuming total absorption of ciprofloxacin from the ear of a
patient treated with CIPRODEX® Otic twice per day according to label
directions.Long term studies have not been performed to evaluate the carcinogenic
potential of topical otic dexamethasone. Dexamethasone has been tested for in vitro and in vivo genotoxic
potential and shown to be positive in the following assays; chromosomal
aberrations, sister-chromatid exchange in human lymphocytes and micronuclei and
sister-chromatid exchanges in mouse bone marrow. However, the Ames/Salmonella
assay, both with and without S9 mix, did not show any increase in His+
revertants.The effect of dexamethasone on fertility has not been investigated following
topical otic application. However, the lowest toxic dose of dexamethasone
identified following topical dermal application was 1.802 mg/kg in a 26-week
study in male rats and resulted in changes to the testes, epididymis, sperm
duct, prostate, seminal vessicle, Cowper’s gland and accessory glands. The
relevance of this study for short term topical otic use is unknown.PregnancyTeratogenic EffectsPregnancy Category C: Reproduction
studies have been performed in rats and mice using oral doses of up to 100 mg/kg
and IV doses up to 30 mg/kg and have revealed no evidence of harm to the fetus
as a result of ciprofloxacin. In rabbits, ciprofloxacin (30 and 100 mg/kg
orally) produced gastrointestinal disturbances resulting in maternal weight loss
and an increased incidence of abortion, but no teratogenicity was observed at
either dose. After intravenous administration of doses up to 20 mg/kg, no
maternal toxicity was produced in the rabbit, and no embryotoxicity or
teratogenicity was observed.Corticosteroids are generally teratogenic in laboratory animals when
administered systemically at relatively low dosage levels. The more potent
corticosteroids have been shown to be teratogenic after dermal application in
laboratory animals.Animal reproduction studies have not been conducted with CIPRODEX® Otic. No
adequate and well controlled studies have been performed in pregnant women.
Caution should be exercised when CIPRODEX® Otic is used by a pregnant
woman.Nursing MothersCiprofloxacin and corticosteroids, as a class, appear in milk
following oral administration. Dexamethasone in breast milk could suppress
growth, interfere with endogenous corticosteroid production, or cause other
untoward effects. It is not known whether topical otic administration of
ciprofloxacin or dexamethasone could result in sufficient systemic absorption to
produce detectable quantities in human milk. Because of the potential for
unwanted effects in nursing infants, a decision should be made whether to
discontinue nursing or to discontinue the drug, taking into account the
importance of the drug to the mother.Pediatric UseThe safety and efficacy of CIPRODEX® Otic have been established
in pediatric patients 6 months and older (937 patients) in adequate and
well-controlled clinical trials. Although no data are available on patients less
than age 6 months, there are no known safety concerns or differences in the
disease process in this population that would preclude use of this product. (See
DOSAGE AND ADMINISTRATION.)No clinically relevant changes in hearing function were observed in 69
pediatric patients (age 4 to 12 years) treated with CIPRODEX® Otic and tested
for audiometric parameters.

Adverse Reactions

In Phases II and III clinical trials, a total of 937 patients
were treated with CIPRODEX® Otic. This included 400 patients with acute otitis
media with tympanostomy tubes and 537 patients with acute otitis externa. The
reported treatment-related adverse events are listed below:Acute Otitis Media in pediatric
patients with tympanostomy tubesThe following
treatment-related adverse events occurred in 0.5% or more of the patients with
non-intact tympanic membranes.Adverse EventIncidence (N=400)Ear discomfort3.0%Ear pain2.3%Ear precipitate(residue)0.5%Irritability0.5%Taste perversion0.5%The following treatment-related adverse events were each reported in a single
patient: tympanostomy tube blockage; ear pruritus; tinnitus; oral moniliasis;
crying; dizziness; and erythema.Acute Otitis ExternaThe following treatment-related adverse events occurred in 0.4% or more of
the patients with intact tympanic membranes.Adverse EventIncidence (N=537)Ear pruritus1.5%Ear debris0.6%Superimposed earinfection0.6%Ear congestion0.4%Ear pain0.4%Erythema0.4%The following treatment-related adverse events occurred in 0.4% or more of
the patients with intact tympanic membranes. The following treatment-related
adverse events were each reported in a single patient: ear discomfort; decreased
hearing; and ear disorder (tingling).

Dosage And Administration

CIPRODEX® OTIC SHOULD BE SHAKEN WELL IMMEDIATELY
BEFORE USECIPRODEX® Otic contains 3 mg/mL (3000 µg/mL) ciprofloxacin and 1 mg/mL
dexamethasone.Acute Otitis Media in pediatric patients with tympanostomy
tubes: The recommended dosage regimen for the treatment of acute otitis
media in pediatric patients (age 6 months and older) through tympanostomy tubes
is:Four drops (0.14 mL, 0.42 mg ciprofloxacin, 0.14 mg dexamethasone) instilled
into the affected ear twice daily for seven days. The suspension should be
warmed by holding the bottle in the hand for one or two minutes to avoid
dizziness, which may result from the instillation of a cold suspension. The
patient should lie with the affected ear upward, and then the drops should be
instilled. The tragus should then be pumped 5 times by pushing inward to
facilitate penetration of the drops into the middle ear. This position should be
maintained for 60 seconds. Repeat, if necessary, for the opposite ear. Discard
unused portion after therapy is completed.Acute Otitis Externa: The recommended dosage regimen
for the treatment of acute otitis externa is: For patients (age 6 months and
older): Four drops (0.14 mL, 0.42 mg ciprofloxacin, 0.14 mg dexamethasone)
instilled into the affected ear twice daily for seven days. The suspension
should be warmed by holding the bottle in the hand for one or two minutes to
avoid dizziness, which may result from the instillation of a cold suspension.
The patient should lie with the affected ear upward, and then the drops should
be instilled. This position should be maintained for 60 seconds to facilitate
penetration of the drops into the ear canal. Repeat, if necessary, for the
opposite ear. Discard unused portion after therapy is completed.

How Supplied

CIPRODEX® (ciprofloxacin 0.3% and dexamethasone 0.1%) Sterile
Otic Suspension is supplied as follows: 7.5 mL fill in a DROP-TAINER® system.
The DROP-TAINER® system consists of a natural polyethylene bottle and natural
plug, with a white polypropylene closure. Tamper evidence is provided with a
shrink band around the closure and neck area of the package.NDC 54868-4928-0,   7.5 mL fillStorageStore at controlled room temperature, 15°C to 30°C (59°F to
86°F). Avoid freezing. Protect from light.

Clinical Studies

In a randomized, multicenter, controlled clinical trial,
CIPRODEX® Otic dosed 2 times per day for 7 days demonstrated clinical cures in
the per protocol analysis in 86% of AOMT patients compared to 79% for ofloxacin
solution, 0.3%, dosed 2 times per day for 10 days. Among culture positive
patients, clinical cures were 90% for CIPRODEX® Otic compared to 79% for
ofloxacin solution, 0.3%. Microbiological eradication rates for these patients
in the same clinical trial were 91% for CIPRODEX® Otic compared to 82% for
ofloxacin solution, 0.3%. In 2 randomized multicenter, controlled clinical
trials, CIPRODEX® Otic dosed 2 times per day for 7 days demonstrated clinical
cures in 87% and 94% of per protocol evaluable AOE patients, respectively,
compared to 84% and 89%, respectively, for otic suspension containing neomycin
0.35%, polymyxin B 10,000 IU/mL, and hydrocortisone 1.0% (neo/poly/HC). Among
culture positive patients clinical cures were 86% and 92% for CIPRODEX® Otic
compared to 84% and 89%, respectively, for neo/poly/HC. Microbiological
eradication rates for these patients in the same clinical trials were 86% and
92% for CIPRODEX® Otic compared to 85% and 85%, respectively, for
neo/poly/HC.

References

1. Campoli-Richards DM, Monk JP, Price A, Benfield P, Todd PA,
Ward A. Ciprofloxacin: A review of its antibacterial activity, pharmacokinetic
properties and therapeutic use. Drugs 1988;35:373-447.2. Loew D, Schuster O, and Graul E. Dose-dependent pharmacokinetics of
dexamethasone. Eur J Clin Pharmacol 1986;30:225-230.U.S. Patent Nos. 4,844,902; 6,284,804; 6,359,016CIPRODEX® is a registered
trademark of Bayer AG.Licensed to Alcon, Inc. by Bayer AG.Manufactured
by Alcon Laboratories, Inc.Rx Only©2003, 2004 Alcon, Inc.Revision
date: 17 July 2003Relabeling of "Additional Barcode Label" by:Physicians Total Care, Inc.Tulsa, OK      74146

Spl Patient Package Insert

CIPRODEX® (CI-PRO-DEX)(ciprofloxacin 0.3% and dexamethasone
0.1%)Sterile Otic SuspensionIMPORTANT PATIENT INFORMATION AND INSTRUCTIONS. READ BEFORE
USE.What is CIPRODEX® Otic?CIPRODEX® Otic is an
antibiotic/steroid combination product in a sterile suspension used to
treat:• Middle Ear Infection with Drainage Through a Tube in
Children 6 months and older: A middle ear infection is a bacterial
infection behind the eardrum. People with a tube in the eardrum may notice
drainage from the ear canal.• Outer Ear Canal Infection in Patients 6 months and
older: An outer ear canal infection, also known as "Swimmer's Ear", is a
bacterial infection of the outer ear canal. The ear
canal and the outer part of the ear may swell, turn red,
and be painful. Also, a fluid discharge may appear in
the ear canal.Who should NOT use CIPRODEX® Otic?• Do not use
this product if allergic to ciprofloxacin or to other quinolone
antibiotics.• Do not use this product if allergic to dexamethasone or to
other steroids.• Do not give this product to pediatric patients who are less
than 6 months old.How often should CIPRODEX® Otic be given?CIPRODEX® Otic ear drops should be given 2 times each day (about 12 hours
apart, for example, 8 AM and 8 PM) in each infected ear unless the doctor has
instructed otherwise. The best times to use the ear drops are in the morning and
at night. It is very important to use the ear drops for as long as the doctor
has instructed, even if the symptoms improve. If
CIPRODEX® Otic ear drops are not used for as long as the doctor has instructed,
the infection may return.What if a dose is missed?If a dose of CIPRODEX®
Otic is missed, it should be given as soon as possible. If it is almost time for
the next dose, skip the missed dose and go back to the regular dosing schedule.
Do not use a double dose unless the doctor has instructed you to do so. If the
infection is not improved after one week, you should consult your doctor. If you
have two or more episodes of drainage within six months, it is recommended you
see your doctor for further evaluation.What activities should be avoided while using CIPRODEX®
Otic?It is important that the infected ear(s) remain clean and dry.
When bathing, avoid getting the infected ear(s) wet. Avoid swimming unless the
doctor has instructed otherwise.What are the possible side effects of CIPRODEX® Otic?During the testing of CIPRODEX® Otic for middle ear infections, the most
common side effect related to CIPRODEX® Otic was ear discomfort that occurred in
up to 3 out of 100 patients. Other common side effects were: ear pain; ear
precipitate (residue); irritability; and abnormal taste. During the testing of
CIPRODEX® Otic for ear canal infections, the most common side effect related to
CIPRODEX® Otic was itching of the ear that occurred in 1 to 2 out of 100
patients. Other common side effects were: ear debris; ear infection in the
treated ear; ear congestion; ear pain; and rash.If any of these side effects persist, call the doctor.If an allergic reaction to CIPRODEX® Otic occurs, stop using the product and
contact your doctor.DO NOT TAKE BY MOUTHIf CIPRODEX® Otic is
accidentally swallowed or overdose occurs, call the doctor immediately. This
medicine is available only with a doctor's prescription. Use only as directed.
Do not use this medicine if outdated. If you wish to learn more about CIPRODEX®
Otic, call your doctor or pharmacist.HOW SUPPLIEDCIPRODEX® Otic is supplied as follows: 7.5 mL fill in a DROP-TAINER® system.
The DROP-TAINER® system consists of a natural polyethylene bottle and natural
plug, with a white polypropylene closure. Tamper evidence is provided with a
shrink band around the closure and neck area of the package.NDC
0065-8533-02, 7.5 mL fillStorageStore at controlled room temperature, 15°C to 30°C (59°F to
86°F). Avoid freezing. Protect from light.U.S. Patent Nos. 4,844,902;
6,284,804; 6,359,016CIPRODEX® is a registered trademark of Bayer
AG.Licensed to Alcon, Inc. by Bayer AG.Manufactured by Alcon
Laboratories, Inc.Rx Only©2003, 2004 Alcon, Inc.How should CIPRODEX® Otic be given?1. Wash handsThe person giving CIPRODEX® Otic should wash his/her hands with soap and
water.2. Warm & shake bottleHold the bottle of CIPRODEX® Otic in the hand for one or two minutes to warm
the suspension, then shake well.3. Add dropsThe person receiving CIPRODEX® Otic should lie on his/her side with the
infected ear up.Patients should have 4 drops of CIPRODEX® Otic put into the infected ear. The
tip of the bottle should not touch the fingers, or the ear, or any other
surfaces.BE SURE TO FOLLOW INSTRUCTIONS BELOW FOR THE PATIENT'S
SPECIFIC EAR INFECTION.4. For Patients with Middle Ear Infection with Tubes:While the person receiving CIPRODEX® Otic lies on his/her side, the person
giving the drops should gently press the tragus (see diagram) 5 times in a
pumping motion. This will allow the drops to pass through the tube in the
eardrum and into the middle ear.5. For Patients with Outer Ear Infection ("Swimmer's
Ear"):While the person receiving the drops lies on his/her side, the person giving
the drops should gently pull the outer ear lobe upward and backward. This will
allow the ear drops to flow down into the ear canal.6. Stay on sideThe person who received the ear drops should remain on his/her side for at
least 60 seconds.Repeat Steps 2-5 for the other ear if both ears are infected.

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