Hydrocortisone Acetate, Iodoquinol
Bowyn Labs, Llc
Human Prescription Drug
NDC 52191-352Hydrocortisone Acetate, Iodoquinol is a human prescription drug labeled by 'Bowyn Labs, Llc'. National Drug Code (NDC) number for Hydrocortisone Acetate, Iodoquinol is 52191-352. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Hydrocortisone Acetate, Iodoquinol drug includes Hydrocortisone Acetate - 19 mg/g Iodoquinol - 10 mg/g . The currest status of Hydrocortisone Acetate, Iodoquinol drug is Active.
Drug Information:
| Drug NDC: | 52191-352 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Hydrocortisone Acetate, Iodoquinol |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Hydrocortisone Acetate, Iodoquinol |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Bowyn Labs, Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Cream |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | HYDROCORTISONE ACETATE - 19 mg/g
IODOQUINOL - 10 mg/g
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | UNAPPROVED DRUG OTHER |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 29 Jul, 2011 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 25 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Bowyn Labs, LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1436947
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | 3X7931PO74
63W7IE88K8
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class: | Corticosteroid Hormone Receptor Agonists [MoA]
Corticosteroid [EPC]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 52191-352-30 | 30 PACKET in 1 CARTON (52191-352-30) / 2 g in 1 PACKET (52191-352-01) | 29 Jul, 2011 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Hydrocortisone acetate, iodoquinol hydrocortisone acetate, iodoquinol hydrocortisone acetate hydrocortisone iodoquinol iodoquinol aloe vera leaf aminomethylpropanol benzyl alcohol carbomer 934 anhydrous citric acid d&c yellow no. 10 fd&c blue no. 1 glycerin polacrilin magnesium aluminum silicate palmitoyl tripeptide-1 ppg-20 methyl glucose ether propylene glycol water alcohol
Indications and Usage:
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: âpossiblyâ 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); monliasis; intertrigo. final classification of the less-than-effective indications requires further investigation.
Warnings and Cautions:
Warnings: keep out of reach of children. precautions: for external use only. not for ophthalmic use. 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. parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings. iodoquinol may be absorbed through the skin and interfere with thy
Read more...roid 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.
Dosage and Administration:
Dosage and administration: apply to affected area(s) three to four times per day or as directed by a physician.
Contraindications:
Contraindications: this product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product.
Adverse Reactions:
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.
Description:
Description: each gram contains 19 mg of hydrocortisone acetate and 10 mg iodoquinol in a vehicle consisting of: aloe vera powder, amino methylpropanol 95%, benzyl alcohol, carbomer, citric acid anhydrous, d&c yellow #10, fd&c blue #1, glycerin, glyceryl polymethacrylate, magnesium aluminum silicate, palmitoyl oligopeptide, ppg-20 methyl glucose ether, propylene glycol, purified water and sd alcohol 40b. hydrocortisone acetate is an anti-inflammatory and antipruritic agent. chemically, hydrocortisone acetate is [pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-, (11-Ã)-] with the molecular formula (c 23 h 32 o 6 ) and is represented by the following structural formula: iodoquinol is an antifungal and antibacterial agent. chemically, iodoquinol is [5,7-diiodo-8-quinolinol] with the molecular formula (c 9 h 5 i 2 no) and is represented by the following structural formula: structure1.jpg structure2.jpg
Clinical Pharmacology:
Clinical pharmacology: hydrocortisone acetate 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. iodoquinol 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 acetate 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 acetate is metabolized in the liver and most body tissue to hydrogenated and degraded forms such as tetrahydr
Read more...ocortisone and tetrahydrocortisol. these are excreted in the urine, mainly conjugated as glucuronides, together with a very small proportion of unchanged hydrocortisone acetate. 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.
How Supplied:
How supplied: this product is supplied in the following size(s): carton, ndc 52191-352-30, containing 30 sachets (net wt. 2 g each). each sachet is a unit of use - discard after opening. to report a serious adverse event or obtain product information, call 1-855-899-4237. manufactured for: bowyn labs, llc 13785 research blvd., suite 125 austin, tx 78750 827515 v3 rev. 05/2017
Package Label Principal Display Panel:
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