HYDROCORTISONE IODOQUINOL- hydrocortisone, iodoquinol cream

hydrocortisone iodoquinol by

Drug Labeling and Warnings

hydrocortisone iodoquinol by is a Prescription medication manufactured, distributed, or labeled by Seton Pharmaceuticals, Monarch PCM, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Rx Only

DESCRIPTION:

Each gram contains 10 mg of hydrocortisone and 10 mg of iodoquinol in a vehicle consisting of: ceteareth-6, ceteareth-25, cetyl alcohol, chloroxylenol, citric acid, glyceryl stearate SE, mineral oil, propylene glycol, purified water, stearyl alcohol, and xanthan gum.

Paraben Free.

Chemically, hydrocortisone is [Pregn-4-ene-3, 20-dione, 11, 17, 21-trihydroxy-,(11 B)-1 with the molecular formula (C21 H3005) and is represented by the following structural formula:

and iodoquinol, 5,7-diiodo-8-quinolinol (C9H5l2NO) is represented by the following structural formula:

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

CLINICAL PHARMACOLOGY:

Hydrocortisone has 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 therapeutic efficacy in humans. lodoquinol has both antifungal and antibacterial properties.

Pharmacokinetics:

The extent of 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 hydrogenated 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 a 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 use on infants or under diapers or 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.

lodoquinol 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 in 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.

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 SUPPLIED:

1 oz. tubes, NDC 13925-175-01

To report a serious adverse event or obtain product information, call 1-855-899-4237.

Manufactured for:

Seton Pharmaceuticals

Manasquan, NJ 08736

1-800-510-3401

v1 Rev. 10/2018

Principal Display Panel:

​NDC: 13925-175-01

Rx Only

​Hydrocortisone 1%-Iodoquinol 1%

​Cream

​Net Wt 1 oz (28.4g)

​Caution:  For external use only. Not for ophthalmic use.

If Irritation or sensitivity occurs or infection appears, discontinue use.

All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. This product may be administered only under a physicia's supervision. There are no implied or explicit claims on the therapeutic equivalence.

​Call your doctor about side effects.

​You may report side effects to the FDA at 1-800-FDA-1088.

​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). Protect from freezing and excessive heat. Keep container tightly closed. Lot number and expiration date are on the crimp of the tube.

​Dosage and Indications:​ See package insert for dosage informatio.

​Description:​ Contains Hydrocortisone 1% and Iodoquinol 1% in a greaseless cream of ceteareth-25, ceteareth-6, cetyl alcohol, chloroxylenol, citric acid, glyceryl stearate SE, mineral oil, propylene glycol, purified water, stearyl alcohol, xanthan gum.

​Paraban Free

​WARNING:​ Keep out of reach of children. For external use only. Avoid contact with eyes. May stain skin, hair or fabrics.

Marketed by:

​Seton Pharmaceuticals

​Manasquan, NJ

08736

1-800-510-3401

rev 10/2018

INGREDIENTS AND APPEARANCE

HYDROCORTISONE IODOQUINOL 
hydrocortisone, iodoquinol cream

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 13925-175
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	10 mg  in 1 g
IODOQUINOL (UNII: 63W7IE88K8) (IODOQUINOL - UNII:63W7IE88K8)	IODOQUINOL	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CETEARETH-6 (UNII: 2RJS3559D3)
CETEARETH-25 (UNII: 8FA93U5T67)
CETYL ALCOHOL (UNII: 936JST6JCN)
CHLOROXYLENOL (UNII: 0F32U78V2Q)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
MINERAL OIL (UNII: T5L8T28FGP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13925-175-01	28.4 g in 1 TUBE; Type 0: Not a Combination Product	01/28/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/28/2019

Labeler - Seton Pharmaceuticals (828898002)

Establishment
Name	Address	ID/FEI	Business Operations
Monarch PCM, LLC		080000294	manufacture(13925-175)