NDC 13925-175 Hydrocortisone Iodoquinol

Hydrocortisone, Iodoquinol

NDC Product Code 13925-175

NDC Code: 13925-175

Proprietary Name: Hydrocortisone Iodoquinol Additional informationCallout TooltipWhat 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.

Non-Proprietary Name: Hydrocortisone, Iodoquinol Additional informationCallout TooltipWhat is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.


Code Structure
  • 13925 - Seton Pharmaceuticals
    • 13925-175 - Hydrocortisone Iodoquinol

NDC 13925-175-01

Package Description: 28.4 g in 1 TUBE

NDC Product Information

Hydrocortisone Iodoquinol with NDC 13925-175 is a a human prescription drug product labeled by Seton Pharmaceuticals. The generic name of Hydrocortisone Iodoquinol is hydrocortisone, iodoquinol. The product's dosage form is cream and is administered via topical form.

Labeler Name: Seton Pharmaceuticals

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

Product Type: Human Prescription Drug Additional informationCallout TooltipWhat kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.


Hydrocortisone Iodoquinol Active Ingredient(s)

Additional informationCallout TooltipWhat is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • HYDROCORTISONE 10 mg/g
  • IODOQUINOL 10 mg/g

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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.

  • 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)

Administration Route(s)

Additional informationCallout TooltipWhat are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Pharmacological Class(es)

Additional informationCallout TooltipWhat is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Corticosteroid - [EPC] (Established Pharmacologic Class)
  • Corticosteroid Hormone Receptor Agonists - [MoA] (Mechanism of Action)

Product Labeler Information

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

* Please review the disclaimer below.

Hydrocortisone Iodoquinol Product Label Images

Hydrocortisone Iodoquinol 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

Other

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 13925-175-01To report a serious adverse event or obtain product information, call 1-855-899-4237.Manufactured for:Seton PharmaceuticalsManasquan, NJ 087361-800-510-3401v1 Rev. 10/2018

* Please review the disclaimer below.

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