Label: XILAPAK- fluocinolone acetonide kit
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Contains inactivated NDC Code(s)
NDC Code(s): 0299-3921-40, 52565-012-59, 70350-5218-1 - Packager: SOLUTECH PHARMACEUTICALS LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application Authorized Generic
Drug Label Information
Updated November 2, 2017
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- XILAPAK KIT DESCRIPTION
- INDICATION AND USAGE
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DOSAGE AND ADMINISTRATION
Apply Cetaphil Cleanser to the affected area, rub gently and rinse with water. Then apply Fluocinolone Acetonide 0.01% Topical Solution and rub into skin until absorbed. Apply twice a day or as directed by your physician. Cover the affected area with silicone tape at bedtime or as directed by your physician.
- WARNINGS
- CONTRAINDICATIONS
- PRECAUTIONS
- HOW SUPPLIED
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DESCRIPTION
Fluocinolone Acetonide Topical Solution USP, 0.01% is intended for topical administration. The active component is the corticosteroid fluocinolone acetonide, which has the chemical name pregna-1,4-diene-3,20-dione,6,9-difluoro-11,21-dihydroxy16,17[(methylethylidene)bis(oxy)]-, (6α,11β,16α)-. It has the following chemical structure:
Fluocinolone Acetonide Solution USP contains fluocinolone acetonide 0.1 mg/mL in a water-washable base of citric acid and propylene glycol.
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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 the 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
- CONTRAINDICATIONS
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PRECAUTIONS
General
Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glycosuria 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.
As with any topical corticosteroid product, prolonged use may produce atrophy of the skin and subcutaneous tissues. When used on intertriginous or flexor areas, or on the face, this may occur even with short-term use.
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 so 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 HPA axis suppression:
Urinary free cortisol test
ACTH stimulation testCarcinogenesis, 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 a 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 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 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.
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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
HypopigmentationPerioral dermatitis
Allergic contact dermatitis
Maceration of the skin
Secondary infection
Skin atrophy
Striae
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OVERDOSAGE
Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (See PRECAUTIONS).
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DOSAGE AND ADMINISTRATION
Fluocinolone Acetonide Topical Solution is generally applied to the affected area as a thin film from two to four times daily depending on the severity of the condition. In hairy sites, the hair should be parted to allow direct contact with the lesion.
Occlusive dressing 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
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
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Product details
For All Skin Types
- Mild, non-irritating formula
- Softens as it cleans
- Non-comedogenic/fragrance free
- Dermatologist recommended
This gentle, soap-free cleanser was originally formulated for dermatologists, specifically for everyday cleansing of even the most sensitive skin.
- Soothing, non-irritating cleanser ideal for face, hands and body
- Helps skin retain needed moisture
- Rinses easily and leaves skin feeling soft, smooth and healthy
Ingredients: Water, Cetyl Alcohol, Propylene Glycol, Sodium Lauryl Sulfate, Stearyl Alcohol, Methylparaben, Propylparaben, Butylparaben
Cetaphil Cleanser is easy to use:
Directions for use with water: Apply cleanser and gently massage into skin. Rinse.
Directions for use without Water: Apply a liberal amount to the skin and rub gently. Remove excess with a soft cloth, leaving a thin film of CETAPHIL on the skin.
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Warnings
For external use only.
Ask a doctor or pharmacist if it is safe for you to use this medicine if you have:
- Deep wounds or open sores;
- Swelling, warmth, redness, oozing, or bleeding on the site of application;
- Large areas of skin irritation;
- Any type of allergy; or
- If you are pregnant or breast-feeding.
- Contraindications
- Side Effects
- SPL UNCLASSIFIED SECTION
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Description
Silicone tape is a silicone blended tape. This tape is designed to not harm the skin when it is being removed. Most tapes pull the skin and the small hairs, causing unnecessary damage. This Silicone tape has a paper blended backing that allows a gentle, but strong adhesion to the skin that remains constant. Most tapes increase their adhesion over time, which increases the damage when they are removed.
The silicone tape can be re-positioned without losing any of its tacky qualities. The gentle adhesion does not lower the quality of the hold either. This tape is adhesive enough that it can be worn in the shower without losing effectiveness.
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Purpose
For alleviating tension on the scar and its surrounding skin. Tension on a wound and scar is known to increase scar tissue formation.
Because of its adherence, silicone tape reduces tension (e.g. tear and stretch) along the incision line or wound which is known to minimize the degree of scarring in terms of spreading or thickening.
- Warnings
- Precautions
- Directions
- PRINCIPAL DISPLAY PANEL - Kit Carton
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INGREDIENTS AND APPEARANCE
XILAPAK
fluocinolone acetonide kitProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70350-5218 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70350-5218-1 1 in 1 CARTON 11/01/2017 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE, WITH APPLICATOR 60 mL Part 2 1 BOTTLE 118 mL Part 1 of 2 FLUOCINOLONE ACETONIDE
fluocinolone acetonide solutionProduct Information Item Code (Source) NDC:52565-012 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FLUOCINOLONE ACETONIDE (UNII: 0CD5FD6S2M) (FLUOCINOLONE ACETONIDE - UNII:0CD5FD6S2M) FLUOCINOLONE ACETONIDE 0.1 mg in 1 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52565-012-59 1 in 1 CARTON 1 60 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA authorized generic NDA015296 11/27/2012 Part 2 of 2 CETAPHIL CLEANSER
cleansing (cold creams, cleansing lotions, liquids, and pads) rinseProduct Information Item Code (Source) NHRIC:0299-3921 Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR Water (UNII: 059QF0KO0R) INGR CETYL ALCOHOL (UNII: 936JST6JCN) INGR PROPYLENE GLYCOL (UNII: 6DC9Q167V3) INGR SODIUM LAURYL SULFATE (UNII: 368GB5141J) INGR STEARYL ALCOHOL (UNII: 2KR89I4H1Y) INGR METHYLPARABEN (UNII: A2I8C7HI9T) INGR PROPYLPARABEN (UNII: Z8IX2SC1OH) INGR BUTYLPARABEN (UNII: 3QPI1U3FV8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:0299-3921-40 118 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA authorized generic NDA015296 11/01/2017 Labeler - SOLUTECH PHARMACEUTICALS LLC (080040396)
