NDC 67857-804 Cloderm

Clocortolone Pivalate

NDC Product Code 67857-804

NDC 67857-804-45

Package Description: 45 g in 1 TUBE

NDC 67857-804-48

Package Description: 10 TUBE in 1 CARTON > 2 g in 1 TUBE (67857-804-23)

NDC 67857-804-51

Package Description: 75 g in 1 BOTTLE, PUMP

NDC 67857-804-90

Package Description: 90 g in 1 TUBE

NDC Product Information

Cloderm with NDC 67857-804 is a a human prescription drug product labeled by Promius Pharma, Llc. The generic name of Cloderm is clocortolone pivalate. The product's dosage form is cream and is administered via topical form.

Labeler Name: Promius Pharma, Llc

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 What 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.

Cloderm Active Ingredient(s)

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

  • CLOCORTOLONE PIVALATE .001 g/g

Inactive Ingredient(s)

About 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.

  • WATER (UNII: 059QF0KO0R)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
  • POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)
  • CARBOMER HOMOPOLYMER TYPE B (UNII: HHT01ZNK31)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)

Administration Route(s)

What 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)

What 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

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Promius Pharma, Llc
Labeler Code: 67857
FDA Application Number: NDA017765 What is the FDA Application Number?
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.

Marketing Category: NDA - A product marketed under an approved New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 08-22-1977 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Cloderm Product Label Images

Cloderm 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

Description:

Cloderm 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:

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. 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.

Indications And Usage:

Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Contraindications:

Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

General:

Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients.Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings.Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid.Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity. (See PRECAUTIONS - Pediatric Use).If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted.In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled.

Information For The Patient:

  • Patients using topical corticosteroids should receive the following information and instructions:This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.Patients should be advised not to use this medication for any disorder other than for which it was prescribed.The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician.Patients should report any signs of local adverse reactions especially under occlusive dressing.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.

Laboratory Tests:

The following tests may be helpful in evaluating the HPA axis suppression: Urinary free cortisol test ACTH stimulation test

Carcinogenesis, Mutagenesis, And 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 have revealed negative results.

Pregnancy Category C:

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.

Nursing Mothers:

It is not known whether topical administration of corticosteroids
could result in sufficient systemic absorption to produce detectable
quantities in breast milk. Systemically administered corticosteroids are
secreted into breast milk in quantities not likely to have deleterious
effect on the infant. Nevertheless, caution should be exercised when
topical corticosteroids are administered to a nursing woman.

Pediatric Use:

Pediatric patients may demonstrate greater susceptibility to
topical corticosteroid-induced HPA axis suppression and Cushing's
syndrome than mature patients because of a larger skin surface area body
weight ratio. Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's
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.

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:

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).

Dosage And Administration:

Apply Cloderm (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 or recalcitrant conditions. If an infection develops, the use of occlusive dressings should be discontinued and appropriate anti-microbial therapy instituted.

How Supplied:

Cloderm (clocortolone pivalate) Cream 0.1% is supplied in 75 gram pump bottles, 45 gram and 90 gram tubes.75 gram pump bottleNDC 67857-804-5145 gram tubeNDC 67857-804-4590 gram tubeNDC 67857-804-90

Storage:

Store Cloderm Cream between 15° and 30° C (59° and 86° F). Avoid freezing.

Other

Distributed by: Promius Pharma, LLCPrinceton, NJ 08540 Cloderm® is a trademark of Coria Laboratories, LTD.Manufactured by: DPT LABORATORIES, LTD. San Antonio, Texas 78215R 0617

* Please review the disclaimer below.