Kenalog
Triamcinolone Acetonide
Sun Pharmaceutical Industries, Inc.
Human Prescription Drug
NDC 10631-093Kenalog also known as Triamcinolone Acetonide is a human prescription drug labeled by 'Sun Pharmaceutical Industries, Inc.'. National Drug Code (NDC) number for Kenalog is 10631-093. This drug is available in dosage form of Aerosol, Spray. The names of the active, medicinal ingredients in Kenalog drug includes Triamcinolone Acetonide - .147 mg/g . The currest status of Kenalog drug is Active.
Drug Information:
| Drug NDC: | 10631-093 |
| 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: | Kenalog |
| 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: | Triamcinolone Acetonide |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Sun Pharmaceutical Industries, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Aerosol, Spray |
| 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: | TRIAMCINOLONE ACETONIDE - .147 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: | NDA |
| 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: | 19 May, 2009 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 19 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. |
| Application Number: | NDA012104 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| 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: | Sun Pharmaceutical Industries, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1085736
1085738
|
| 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. |
| NUI: | N0000175576
N0000175450
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | F446C597KA
|
| 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 MOA: | Corticosteroid Hormone Receptor Agonists [MoA]
|
| Mechanism of action of the drug—molecular, subcellular, or cellular functional activity—of the drug’s established pharmacologic class. Takes the form of the mechanism of action, followed by `[MoA]` (such as `Calcium Channel Antagonists [MoA]` or `Tumor Necrosis Factor Receptor Blocking Activity [MoA]`. |
| Pharmacologic Class EPC: | Corticosteroid [EPC]
|
| Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`. |
| 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 |
|---|
| 10631-093-07 | 100 g in 1 CAN (10631-093-07) | 19 May, 2009 | N/A | No |
| 10631-093-62 | 63 g in 1 CAN (10631-093-62) | 19 May, 2009 | N/A | No |
| 10631-093-96 | 6 CAN in 1 CARTON (10631-093-96) / 15 g in 1 CAN (10631-093-35) | 19 May, 2009 | 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:
Kenalog triamcinolone acetonide triamcinolone acetonide triamcinolone acetonide isopropyl palmitate isobutane alcohol
Indications and Usage:
Indications and usage kenalog spray (triamcinolone acetonide topical aerosol, usp) is indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Dosage and Administration:
Dosage and administration directions for use of the spray can are provided on the label. the preparation may be applied to any area of the body, but when it is sprayed about the face, care should be taken to see that the eyes are covered, and that inhalation of the spray is avoided. spray is flammable; avoid heat, flame or smoking when using this product. three or four applications daily of kenalog spray (triamcinolone acetonide topical aerosol) are generally adequate.
Contraindications:
Contraindications topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.
Adverse Reactions:
Adverse reactions the following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings (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 infection, skin atrophy, striae, and miliaria.
Use in Pregnancy:
Pregnancy: teratogenic effects corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. the more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. there are no adequate and well-controlled studies in pregnant women on 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.
Pediatric Use:
Pediatric use pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced hpa axis suppression and cushingâs syndrome than mature patients because of a larger skin surface area to body weight ratio. hpa axis suppression, cushingâs 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. manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. chronic corticosteroid therapy may interfere with the growth and development of children.
Overdosage:
Overdosage topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see precautions , general ).
Description:
Description the topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. the steroids in this class include triamcinolone acetonide. triamcinolone acetonide is designated chemically as 9-fluoro-11β , 16α, 17, 21-tetrahydroxypregna-1, 4-diene-3, 20-dione cyclic 16, 17-acetal with acetone. the structural formula is: c 24 h 31 fo 6 , mw 434.50 a two-second application, which covers an area approximately the size of the hand, delivers an amount of triamcinolone acetonide not exceeding 0.2 mg. after spraying, the nonvolatile vehicle remaining on the skin contains approximately 0.2% triamcinolone acetonide. each gram of spray provides 0.147 mg triamcinolone acetonide in a vehicle of isopropyl palmitate, dehydrated alcohol (10.3%), and isobutane propellant. structure
Clinical Pharmacology:
Clinical pharmacology topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions. the mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. there is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man. pharmacokinetics the extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. 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 adminis
Read more...tered 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.
Carcinogenesis and Mutagenesis and Impairment of Fertility:
Carcinogenesis, mutagenesis, impairment of fertility long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids. studies to determine mutagenicity with prednisolone and hydrocortisone showed negative results.
How Supplied:
How supplied kenalog spray (triamcinolone acetonide topical aerosol, usp) is a clear, colorless liquid that is practically free from visible impurities. it has an odor characteristic of ethanol. it is supplied as follows: 63 g (ndc 10631-093-62) aerosol can. 100 g (ndc 10631-093-07) aerosol can. storage and handling store at room temperature; avoid excessive heat. contents under pressure; do not puncture or incinerate. keep out of reach of children. to report suspected adverse reactions, contact the fda at 1-800-fda-1088 or www.fda.gov/medwatch . manufactured by: dpt laboratories inc. san antonio, tx 78215 distributed by: sun pharmaceutical industries, inc. cranbury, nj 08512 revised may 2018
Information for Patients:
Information for the patient patients using kenalog spray should receive the following information and instructions: 1. this medication is to be used as directed by the physician. it is for external use only; avoid contact with the eyes and inhalation of the spray. 2. patients should be advised not to use this medication for any disorder other than for which it was prescribed. 3. the treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician. 4. patients should report any signs of local adverse reactions. 5. 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. 6. do not use kenalog spray on the underarms or groin areas unless directed by your physician. 7. if no improvement is seen within 2 weeks, contact your physician. 8. do not use other corticosteroid-containing products while
Read more... using kenalog spray without first consulting your physician. 9. kenalog spray is flammable. avoid heat, flames or smoking when applying kenalog spray.
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Package/label display panel- 15 g carton carton
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Package label- 63 g label 63 g label 63 g carton label 100 g label 100 g carton