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Corti Sav Cream

Package insert / prescribing information
Generic name: hydrocortisone and iodoquinol
Dosage form: cream

Medically reviewed by Drugs.com. Last updated on Jul 1, 2021.

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

Corti Sav Cream Description

Contains hydrocortisone 1% and iodoquinol 1% in a greaseless cream of cetyl alcohol, glyceryl monostearate SE, isopropyl myristate, lanolin alcohol, mineral oil, polyoxyl 40 stearate, polysorbate 20, polysorbate 60, propylene glycol, purified water, sorbic acid, and sorbitan monostearate.

Paraben Free.

Chemically, hydrocortisone is [Pregn-4-ene-3, 20-dione, 11, 17, 21-trihydroxy-, (11β)-] with the molecular formula C 21H 30O 5) and is represented by the following structural formula:

and iodoquinol, 5, 7-diiodo-8-quinolinol (C 9H 5I 2NO) is represented by the following structural formula:

Hydrocortisone is an anti-inflammatory and antipruritic agent, while iodoquinol is an antifungal and antibacterial agent.

Corti Sav Cream - Clinical Pharmacology

Hydrocortisone has an anti-inflammatory, antipruritic and vasoconstrictive properties. While the mechanism of anti-inflammatory activity is unclear, there is evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and the therapeutic efficacy in humans lodoquinol has both antifungal and antibacterial properties.

Pharmacokinetics

The extent of the percutaneous absorption of topical steroids is determined by many factors including the vehicle, the integrity of the epidermal barrier and the use of occlusive dressings. Hydrocortisone can be absorbed from normal intact skin. Inflammation and/or other inflammatory disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Once absorbed through the skin, hydrocortisone is metabolized in the liver and most body tissue to hydrogeneted and degraded forms such as tetrahydrocortisone and tetrahydrocortisol. These are excreted in the urine, mainly conjugated as glucuronides, together with a very small proportion of unchanged hydrocortisone. There are no data available regarding the percutaneous absorption of iodoquinol; however, following oral administration, 3-5% of the dose was recovered in the urine as glucuronide.

INDICATIONS

Based on a review of a related drug by the National Research Council and subsequent FDA classification for that drug, the indications are as follows: "Possibly" Effective: Contact or atopic dermatitis; impetiginized eczema; nummular eczema; endogenous chronic infectious dermatitis; stasis dermatitis; pyoderma; nuchal eczema and chronic eczematoid otitis externa; acne urticata; localized or disseminated neurodermatitis; lichen simplex chronicus; anogenital pruritus (vulvae, scroti, ani); folliculitis; bacterial dermatoses; mycotic dermatoses such as tinea (capitis, cruris, corporis, pedis); moniliasis; intertrigo. Final classification of the less-than-effective indications requires further investigation.

Contraindications

This product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product.

Warning

FOR EXTERNAL USE ONLY.

Precautions

NOT FOR OPHTHALMIC USE.

KEEP OUT OF REACH OF CHILDREN.

Avoid contact with eyes, lips and mucous membranes.

Information for Patients

If irritation develops, the use of this product should be discontinued and appropriate therapy instituted. Staining of the skin, hair and fabrics may occur. Not intended for the use on infants or under diapers of occlusive dressings. If extensive areas are treated or if the occlusive dressing technique is used, the possibility exists of increased systemic absorption of the corticosteroid, and suitable precautions should be taken.

Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity.

Iodoquinol may be absorbed through the skin and interfere with thyroid function tests. If such tests are contemplated, wait at least one month after discontinuance of therapy to perform these tests. The ferric chloride test for phenylketonuria (PKU) can yield a false positive result if iodoquinol is present in the diaper or urine. Prolonged use may result on overgrowth of non-susceptible organisms requiring appropriate therapy.

Carcinogenesis, Mutagenesis and Impairment of Fertility

Long-term animal studies for carcinogenic potential have not been performed on this product to date. In vitro studies to determine mutagenicity with hydrocortisone have revealed negative results. Mutagenicity studies have not been performed with iodoquinol.

Pregnancy

Category C

Animal reproduction studies have not been conducted with this product. It is also not known whether this product can affect reproduction capacity or cause fetal harm when administered to a pregnant woman. This product should be used by a pregnant woman only if clearly needed or when potential benefits outweigh potential hazards to the fetus.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this product is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients under the age of 12 have not been established.

Adverse Reactions

The following local adverse reactions are reported infrequently with topical corticosteroids. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infections, skin atrophy, striae and miliaria.

Corti Sav Cream Dosage and Administration

Apply to affected area 3 to 4 times daily in accordance with physician's directions.

STORAGE

Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (between 59°F to 86°F). Brief exposure to temperatures up to 40°C (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25°C (77°F); however, such exposure should be minimized. Keep container tightly closed.

NOTICE

Protect from freezing and excessive heat.

How is Corti Sav Cream Supplied

1 oz. tubes, NDC 72336-811-30

To report a serious adverse event or obtain product information, call 1-888-463-6332.

Manufactured for:

LiFsa Drugs LLC
New Brunswick NJ 08901

PRINCIPAL DISPLAY PANEL

NDC 72336-811-30

Corti-Sav

Hydrocortisone 1%−Iodoquinol 1% Cream

NET WT 1 oz (28.4 g)

CORTI-SAV
hydrocortisone and iodoquinol cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:72336-811
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE 10 mg in 1 g
IODOQUINOL (IODOQUINOL) IODOQUINOL 10 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
CETYL ALCOHOL
GLYCERYL STEARATE SE
ISOPROPYL MYRISTATE
LANOLIN ALCOHOLS
MINERAL OIL
POLYOXYL 40 STEARATE
POLYSORBATE 20
POLYSORBATE 60
PROPYLENE GLYCOL
WATER
SORBIC ACID
SORBITAN MONOSTEARATE
Product Characteristics
Color yellow (Light yellow) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description
1 NDC:72336-811-30 1 TUBE in 1 CARTON
1 28.4 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 07/15/2021
Labeler - Lifsa Drugs LLC (081205160)
Lifsa Drugs LLC

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