NDC 54766-716 Pramosone Cream

Hydrocortisone Acetate And Pramoxine Hydrochloride

NDC Product Code 54766-716

NDC 54766-716-03

Package Description: 57 g in 1 TUBE

NDC 54766-716-04

Package Description: 28.4 g in 1 TUBE

NDC Product Information

Pramosone Cream with NDC 54766-716 is a a human prescription drug product labeled by Sebela Pharmaceuticals Inc.. The generic name of Pramosone Cream is hydrocortisone acetate and pramoxine hydrochloride. The product's dosage form is cream and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates multiple RxCUI concepts are associated to this product: 1116499 and 1234519.

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.

Pramosone Cream 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.


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.

  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
  • POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • SORBIC ACID (UNII: X045WJ989B)
  • TRIETHANOLAMINE LAURYL SULFATE (UNII: E8458C1KAA)
  • WATER (UNII: 059QF0KO0R)

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: Sebela Pharmaceuticals Inc.
Labeler Code: 54766
FDA Application Number: ANDA085368 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: ANDA - A product marketed under an approved Abbreviated 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: 08-04-2015 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Information for Patients

Hydrocortisone Topical

Hydrocortisone Topical is pronounced as (hye droe kor' ti sone)

Why is hydrocortisone topical medication prescribed?
Hydrocortisone is available with or without a prescription. Low-strength preparations (0.5% or 1%) are used without a prescription for the temporary relief of (1) minor s...
[Read More]
Pramoxine

Pramoxine is pronounced as (pra mox' een)
Why is pramoxine medication prescribed?
Pramoxine is used to temporarily relieve pain and itching from insect bites; poison ivy, poison oak, or poison sumac; minor cuts, scrapes, or burns; minor skin irritation...
[Read More]

* Please review the disclaimer below.

Pramosone Cream 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

DESCRIPTION: Pramosone ® Cream 1% is a topical preparation
containing hydrocortisone acetate 1% w/w and pramoxine hydrochloride 1% w/w in
a hydrophilic cream base containing stearic acid, cetyl alcohol, Aquaphor





®,
isopropyl palmitate, polyoxyl 40 stearate, propylene glycol, potassium sorbate,
sorbic acid, triethanolamine lauryl sulfate, and purified water.





Topical corticosteroids are anti-inflammatory and
anti-pruritic agents. The structural formula, the chemical name, molecular formula and molecular weight for active ingredients are presented below.hydrocortisone acetate





Pregn-4-ene-3,
20-dione, 21-(acetyloxy)-11, 17-dihydroxy-, (11-beta)-





C





23H





32O





6; mol.wt.: 404.50





pramoxine hydrochloride





4-(3-(p-butoxyphenoxy)propyl)morpholine
hydrochloride





C





17H





27NO





3.HCl; mol. wt.: 329.87

Clinical Pharmacology

CLINICAL PHARMACOLOGY: Topical corticosteroids share anti-inflammatory, anti-pruritic
and vasoconstrictive actions.





The mechanism of anti-inflammatory activity of 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.Pramoxine hydrochloride is a topical anesthetic agent which
provides temporary relief from itching and pain. It acts by stabilizing the
neuronal membrane of nerve endings with which it comes into contact.

Pharmacokinetics

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 & Usage

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

Contraindications

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

Precautions

PRECAUTIONS: 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 and 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 Patients

  • 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 dressings.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

Laboratory Tests: The following tests may be helpful in evaluating the HPA
axis suppression:





Urinary free cortisol test






ACTH stimulation test

Carcinogenesis & Mutagenesis & Impairment Of Fertility

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

Pregnancy: Teratogenic Effects: 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

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

Pediatric Use

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 to 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 fontanels, 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

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:





BurningHypertrichosisMaceration of the skinItchingAcneiform eruptionsSecondary infectionIrritationHypopigmentationSkin atrophyDrynessPerioral dermatitis StriaeFolliculitisAllergic contact dermatitis Miliaria

Overdosage

OVERDOSAGE: Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects. (See





PRECAUTIONS.)

Dosage & Administration

DOSAGE AND ADMINISTRATION: Topical corticosteroids are generally applied to the
affected area as a thin film three to four times daily depending on the
severity of the condition. 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 antimicrobial
therapy instituted.

How Supplied

HOW SUPPLIED:    Pramosone® Cream 1%       1 oz tube (NDC 54766-716-04)





                                                                                   2 oz tube (NDC 54766-716-03)





Storage Conditions: Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].





Rx Only.Manufactured for Sebela Ireland Ltd.By Ferndale Laboratories, Inc., Ferndale, MI 48220 U.S.A.Distributed by Sebela Pharmaceuticals Inc.






645 Hembree Parkway, Suite I






Roswell, GA 30076






www.sebelapharma.com






Toll Free 1-844-732-3521





Aquaphor® is a registered trademark of Beiersdorf AG.






Pramosone® is a registered trademark of Sebela International Limited.






#6988I






PI716041014






©2014 Reproduction prohibited

* Please review the disclaimer below.