Clocortolone Pivalate
Dr. Reddy's Laboratories Inc
Human Prescription Drug
NDC 43598-341Clocortolone Pivalate is a human prescription drug labeled by 'Dr. Reddy's Laboratories Inc'. National Drug Code (NDC) number for Clocortolone Pivalate is 43598-341. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Clocortolone Pivalate drug includes Clocortolone Pivalate - .001 g/g . The currest status of Clocortolone Pivalate drug is Active.
Drug Information:
| Drug NDC: | 43598-341 |
| 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: | Clocortolone Pivalate |
| 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: | Clocortolone Pivalate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Dr. Reddy's Laboratories Inc |
| 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: | CLOCORTOLONE PIVALATE - .001 g/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 AUTHORIZED GENERIC |
| 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: | 17 Feb, 2014 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 21 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: | NDA017765 |
| 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: | Dr. Reddy's Laboratories Inc
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 197520
|
| 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. |
| UPC: | 0343598341750
|
| UPC stands for Universal Product Code. |
| UNII: | QBL8IZH14X
|
| 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 |
|---|
| 43598-341-45 | 1 TUBE in 1 CARTON (43598-341-45) / 45 g in 1 TUBE | 17 Feb, 2014 | N/A | No |
| 43598-341-75 | 1 BOTTLE, PUMP in 1 CARTON (43598-341-75) / 75 g in 1 BOTTLE, PUMP | 17 Feb, 2014 | N/A | No |
| 43598-341-90 | 1 TUBE in 1 CARTON (43598-341-90) / 90 g in 1 TUBE | 17 Feb, 2014 | 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:
Clocortolone pivalate clocortolone pivalate clocortolone pivalate clocortolone water petrolatum mineral oil stearyl alcohol polyoxyl 40 stearate carbomer homopolymer type b (allyl pentaerythritol or allyl sucrose crosslinked) edetate disodium sodium hydroxide methylparaben propylparaben structure bottle carton
Indications and Usage:
Indications and usage topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Dosage and Administration:
Dosage and administration apply clocortolone pivalate cream 0.1% sparingly to the affected areas three times a day and rub in gently. occlusive dressings may be used for the management of psoriasis orrecalcitrant conditions. if an infection develops, the use of occlusive dressings should be discontinued and appropriate anti-microbial therapy instituted.
Contraindications:
Contraindications topical corticosteroids are contraindicated in those patients with ahistory of hypersensitivity to any of the components of the preparation.
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. 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 infection skin atrophy striae miliaria
Overdosage:
Overdosage topically applied corticosteroids can be absorbed in sufficient amountsto produce systemic effects (see precautions ).
Description:
Description clocortolone pivalate cream 0.1% contains the medium potency topical corticosteroid, clocortolone pivalate, in a specially formulated water-washable emollient cream base consisting of purified water, white petrolatum, mineral oil, stearyl alcohol, polyoxyl 40 stearate, carbomer 934p, edetate disodium, sodium hydroxide, with methylparaben and propylparaben as preservatives. chemically, clocortolone pivalate is 9-chloro-6α-fluoro-11β,21-dihydroxy-16α methylpregna-1,4-diene-3, 20-dione 21-pivalate.its structure is as follows:
Clinical Pharmacology:
Clinical pharmacology topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions. the mechanism of anti-inflammatory activity of the topical corticosteroidsis 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.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 di
Read more...sease processes in the skin increasepercutaneous absorption. occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses. (see dosage and administration ). once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered 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.
How Supplied:
How supplied clocortolone pivalate cream 0.1% is supplied in 75 gram pump bottles, 45 gram and 90 gram tubes. 75 gram pump bottle ndc 43598-341-75 45 gram tube ndc 43598-341-45 90 gram tube ndc 43598-341-90
Package Label Principal Display Panel:
Container label - 75 g pump 75 gram bottle label:
Carton label - 75 g pump 75 gram bottle carton label