CORTAINE -B AQUEOUS - hydrocortisone, chloroxylenol and pramoxine hydrochloride solution/ drops 
Physicians Total Care, 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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DESCRIPTION

CortaineTM-BAqueousis an anti-inflammatory, antimicrobial and local anesthetic solution for use in the external ear only.

Each mL contains:
Hydrocortisone........................................................................   10 mg
Chloroxylenol..........................................................................     1 mg
Pramoxine Hydrochloride.........................................................   10 mg


In a bland aqueous vehicle.

Hydrocortisone (cortisol)  (11β)-​11,​17,​21-​trihydroxypregn-​4-​ene-​3,​20-​dione) is an anti-inflammatory and antipruritic agent.  Chloroxylenol (4-chloro-3, 5-dimethyl phenol or meta-chloroxylenol) is a broad spectrum antimicrobial agent.  Pramoxine (4-[3-(4-butoxyphenoxy) propyl-] morpholine), used as the hydrochloride salt, is a topical anesthetic.

CLINICAL PHARMACOLOGY

Cortane-B Aqueous is effective both as an antibacterial and antifungal agent.  The special base is a neutral hydrophillic water based solution having a low surface tension allowing the medication to spread quickly to all contiguous surfaces, softening and reducing accumulated cerumen.


Hydrocortisone  is a corticosteroid which has anti-inflammatory, antipruritic and vasoconstrictive actions.  The mechanism of anti-inflammatory action of topical corticosteroids is unclear.  Topical corticosteroids can be absorbed from normal intact skin.  Inflammation and/or other disease processes in the skin increase percutaneous absorption.  Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically-administered corticosteroids.  Corticosteroids are bound to plasma proteins in varying degrees.  Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys.  Some of the topical corticosteroids and their metabolites are also excreted into the bile.

Chloroxylenol   in low concentrations is a germicide that may be used to treat bacterial and fungal infections.  It is a halogenated phenol, non-toxic, non-corrosive, non-staining with a high phenol coefficient.  It may be applied directly to a wound and shows no chemical reactivity toward blood.

Pramoxine hydrochloride  is a topical anesthetic which is chemically unrelated to procaine and the otehr "caines".  It provides temporary relief from itching and pain by stabilizing the neuronal membranes of nerve endings with which it comes into contact.

INDICATIONS AND USAGE

For the treatment of superficial infections of the external ear caused by microbes, and to control the accompanying inflammation and itching.

CONTRAINDICATIONS

Topical corticosteroids are contraindicated in varicella, vaccinia and in patients sensitive to any of the components of this preparation.  This medication should not be applied in the external auditory canal where there is a perforated eardrum or when this medication can reach the middle ear.

WARNINGS

This product should be used with care in cases of long-standing otitis media because of the possible perforation of the eardrum concomitant with the external ear use of this product.  This preparation is not intended for ophthalmic or oral use.

If irritation or sensitization occurs, promptly discontinue use of this preparation and institute other measures.

PRECAUTIONS

General:  Treatment should not be continued for longer than ten days and the source of the infection and/or inflammation evaluated to determine whether therapy should be changed.

Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pitultary-adrenal (HPA) axis suppression, manifestation of Cushing's syndrome, hyperglycemia and glycosuria in some patients.  Conditions which augment systemic absorption include the application of more potent steroids.  Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug.  Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental corticosteroids.  Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (see Pediatric Use section below).

Information for Patients:  patients using topical corticosteroids should receive the following information and instructions:

Carcinogenesis, Mutagenesis, Impairment of Fertility:  Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effects of topical corticosteroids on fertility.  Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results.

Pregnancy Category C:  Corticosteroids are generally teratogenic in laboratory animals when administered systemically at low dosage levels.  The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals.  There are not adequate and well-controlled studies in pregnant women in teratogenic effects from topically-applied corticosteroids.  Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.  Drugs of this class should not be used extensively on pregnant patients in large amounts, or for prolonged periods of time.

Nursing Mother:  It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk.  Systemically-administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant.  Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman.

PEDIATRIC USE:  Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface to body weight ratio.  Cushing's syndrome and intracranial hypertension have been reported in children receiving topical corticosteroids.  Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels and absence of response to ACTH stimulation.  Manifestation of intracranial hypertension include bulging fontanelles, headaches and bilateral papilledema.

Administration of topical corticosteroids to pediatric patients should be limited to the least amount compatible with an effective therapeutic regime.  Chronic corticosteroid therapy may interfere with the growth and development of children.

ADVERSE REACTIONS

The following local adverse reactions have been reported with topical corticosteroids, especially under occlusive dressings:  burning, itching, irritation, dryness, folliculitis, hypertrichosis, allergic contact dermatitis, skin atrophy, striae and miliaria.

OVERDOSAGE

Topically-applied corticosteroids can be absorbed in sufficient amount to product systemic effects.  Treatment of overdosage should be symptomatic and supportive.

DOSAGE AND ADMINISTRATION

The external ear, that is the auricle and the auditory canal, should be thoroughly cleansed and dried.  Four or 5 drops of the solution should be instilled into the affected ear 3 or 4 times daily.  For infants and small children, 3 drops are suggested because of the smaller capacity of the ear canal.  The patient should lie with the affected ear upward to instill the drops and this position maintained for 1 minute to facilitate penetration of the drops into the ear canal.  Repeat, if necessary, for the opposite affected ear.

If preferred a gauze ear plug or a wick may be used.  For those who use  the Pope Ear WickTM, 7 or more drops are instilled into the affected ear prior to inserting the wick.  The wick will expand once the drops in the ear canal have warmed which should take place in 1 minute or less.  Drops of Cortane-B Aqueous Ear Drops may be added to the gauze ear plug or wick 3 or 4 times daily to keep the ear plug or wick moist.  The ear plug or wick should be removed after 1 day of use.

The gauze ear plug or the expanded wick are easily removed using fingers, forceps or tweezers.

HOW SUPPLIED

Cortane-B Aqueous is supplied in plastic dropper vials of 10 mL.    NDC 54868-6166-0.



KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.  IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

Rx only

Dispense in tight, light resistant containers as defined in the USP/NF.

Store at controlled room temperature 15° - 30°C (59° - 86°F).



Manufactured for:
Blansett Pharmacal Co., Inc.
North Little Rock, AR    72116

Rev. 3/00



Additional barcode labeling by:
Physicians Total Care, Inc.
Tulsa, Oklahoma        74146

image of package label

CORTAINE  -B AQUEOUS
hydrocortisone, chloroxylenol, pramoxine hydrochloride solution/ drops
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:54868-6166(NDC:51674-0118)
Route of AdministrationAURICULAR (OTIC)DEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE10 mg  in 1 mL
CHLOROXYLENOL (CHLOROXYLENOL) CHLOROXYLENOL1 mg  in 1 mL
PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE10 mg  in 1 mL
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:54868-6166-01 VIAL, PLASTIC ( VIAL) in 1 BOXcontains a VIAL, PLASTIC
110 mL in 1 VIAL, PLASTICThis package is contained within the BOX (54868-6166-0)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/09/2010

Labeler - Physicians Total Care, Inc. (194123980)
Establishment
NameAddressID/FEIOperations
Physicians Total Care, Inc.194123980relabel

Revised: 10/2012 Physicians Total Care, Inc.