Label: FLUOCINOLONE ACETONIDE - fluocinolone acetonide cream FLUOCINOLONE ACETONIDE - fluocinolone acetonide ointment 

  • Label RSS
  • NDC Code(s): 0713-0222-15, 0713-0222-60, 0713-0223-15, 0713-0223-60, view more
    0713-0224-15, 0713-0224-60
  • Packager: GW Laboratories, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated 09/11

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  • DESCRIPTION

    The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. Fluocinolone Acetonide is included in this class of synthetic corticosteroids.

    Chemically Fluocinolone Acetonide is Pregna-1,4-diene-3,20-dione, 6,9-difluoro-11,21-dihydroxy-16,17-[(I-methylethylidene)bis(oxy)]-,(6∝,11ß,6∝)-), with the molecular formula C24H30F206, a molecular weight of 452.49 and the following structural formula:

    Chemical Structure

    Each gram of Fluocinolone Acetonide Cream 0.01% contains: 0.1 mg fluocinolone acetonide and each gram of Fluocinolone Acetonide Cream 0.025% contains: 0.25 mg fluocinolone acetonide in a water washable cream base consisting of mineral oil (and) lanolin alcohol, isopropyl palmitate, propylene glycol monostearate, cetyl alcohol, sorbitan monostearate, polysorbate 60, sorbic acid, polyoxyl (40) stearate, purified water, propylene glycol with propylparaben and methylparaben as preservatives.

    Each gram of Fluocinolone Acetonide Ointment 0.025% contains: 0.25 mg of fluocinolone acetonide in an ointment base consisting of light mineral oil and white petrolatum.

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  • CLINICAL PHARMACOLOGY

    Topical corticosteroids share anti-inflammatory, anti-pruritic 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.

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  • INDICATIONS & USAGE

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

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  • CONTRAINDICATIONS

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

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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 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:
    1. This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.
    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 especially under occlusive dressing.
    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.

    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 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, Hypopigmentation, Perioral dermatitis, Allergic contact dermatitis, Maceration of the skin, Secondary infection, Skin Atrophy, Striae and Miliaria.

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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 & ADMINISTRATION

    Topical corticosteroids are generally applied to the affected areas as a thin film from two 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.

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  • HOW SUPPLIED SECTION

    Fluocinolone Acetonide Cream 0.01% USP is supplied in: 15 g tubes NDC 0713-0223-15, 60 g tubes NDC 0713-0223-60
    Fluocinolone Acetonide Cream 0.025% USP is supplied in: 15 g tubes NDC 0713-0222-15, 60 g tubes NDC 0713-0222-60
    Fluocinolone Acetonide Ointment 0.025% USP is supplied in: 15 g tubes NDC 0713-0224-15, 60 g tubes NDC 0713-0224-60

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  • STORAGE AND HANDLING

    Store at controlled room temperature 15°-30° C (59°-86° F).                                              
    Manufactured by: G & W Laboratories, Inc., 111 Coolidge Street, South Plainfield, N.J. 07080
    Rev. 02/11  8-FLUOGW3

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  • PACKAGE LABEL - Fluocinolone Acetonide Cream USP 0.025%

    G&W
    NDC 0713-0222-15
    Fluocinolone Acetonide Cream USP 0.025%
    (Each gram contains 0.25 mg of fluocinolone acetonide USP)
    For dermatologic use only
    Rx only                   15g

    Each gram contains:
    0.25 mg fluocinolone acetonide USP in a water washable cream base consisting of mineral oil (and) lanolin alcohol, isopropyl palmitate, propylene gylcol monostearate, cetyl alcohol, sorbitan monostearate, polysorbate 60, sorbic acid, polyoxyl (40) stearate, purified water, propylene glycol and propylparaben and methylparaben as preservatives.

    WARNING: DO NOT USE IN OR AROUND THE EYE.
    Store at controlled room temperature, 15°-30°C (59°-86°F).

    Usual Dose: Apply a small amount to the affected area two to four times daily.
    For complete information read accompanying insert.

    80% UPC N3-0713-0222-15

    Manufactured by:
    G&W Laboratories, Inc.
    111 Coolidge Street
    South Plainfield, NJ 07080

    Packaging Carton0222
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  • PACKAGE LABEL - Fluocinolone Acetonide Cream USP 0.01%

    G&W
    NDC 0713-0223-15
    Fluocinolone Acetonide Cream USP 0.01%
    (Each gram contains 0.1 mg of fluocinolone acetonide USP)
    For dermatologic use only
    Rx only            15g

    Each gram contains: 0.1 mg fluocinolone acetonide USP in a water washable cream base consisting of mineral oil (and) lanolin alcohol, isopropyl palmitate, propylene gylcol monostearate, cetyl alcohol, sorbitan monostearate, polysorbate 60, sorbic acid, polyoxyl (40) stearate, purified water, propylene glycol and propylparaben and methylparaben as preservatives.

    WARNING: DO NOT USE IN OR AROUND THE EYE.

    Store at controlled room temperature, 15°-30°C (59°-86°F).


    80% UPC N3-0713-0223-15


    Usual Dose: Apply a small amount to the affected area two to four times daily.

    For complete information read accompanying insert.

    Manufactured by:
    G&W Laboratories, Inc.
    111 Coolidge Street
    South Plainfield, NJ 07080

    Packaging Carton0223
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  • PACKAGE LABEL- Fluocinolone Acetonide Ointment, USP 0.025%

    G&W NDC 0713-0224-15
    Fluocinolone Acetonide Ointment USP 0.025%
    For external use only - Not for ophthalmic use.
    Rx only             15 g

    Usual Dose:
    Apply a small amount to the affected area two to four times daily.

    For complete information read accompanying insert.

    Manufactured by:
    G&W Laboratories, Inc.
    111 Coolidge Street
    South Plainfield, NJ 07080

    Each gram contains:
    0.25 mg fluocinolone acetonide USP in an ointment base consisting of light mineral oil and white petrolatum.

    Store at controlled room temperature, 15°-30°C (59°-86°F).

    Packaging Carton Ointment
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  • INGREDIENTS AND APPEARANCE
    FLUOCINOLONE ACETONIDE  
    fluocinolone acetonide cream
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0713-0222
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Fluocinolone Acetonide (Fluocinolone) Fluocinolone Acetonide 0.25 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    Mineral Oil  
    Lanolin Alcohols  
    Isopropyl Palmitate  
    Propylene Glycol Stearate  
    Cetyl Alcohol  
    Sorbitan Monostearate  
    Polysorbate 60  
    Sorbic Acid  
    Polyoxyl 40 Stearate  
    Water  
    Propylene Glycol  
    Propylparaben  
    Methylparaben  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0713-0222-15 15 g in 1 TUBE
    2 NDC:0713-0222-60 60 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA089525 07/26/1988
    FLUOCINOLONE ACETONIDE  
    fluocinolone acetonide cream
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0713-0223
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Fluocinolone Acetonide (Fluocinolone) Fluocinolone Acetonide 0.1 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    Mineral Oil  
    Lanolin Alcohols  
    Isopropyl Palmitate  
    Propylene Glycol Stearate  
    Cetyl Alcohol  
    Sorbitan Monostearate  
    Polysorbate 60  
    Sorbic Acid  
    Polyoxyl 40 Stearate  
    Water  
    Propylene Glycol  
    Propylparaben  
    Methylparaben  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0713-0223-15 15 g in 1 TUBE
    2 NDC:0713-0223-60 60 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA089526 07/26/1988
    FLUOCINOLONE ACETONIDE  
    fluocinolone acetonide ointment
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0713-0224
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Fluocinolone Acetonide (Fluocinolone) Fluocinolone Acetonide 0.25 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    Light Mineral Oil  
    Petrolatum  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0713-0224-15 15 g in 1 TUBE
    2 NDC:0713-0224-60 60 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA089524 07/26/1988
    Labeler - GW Laboratories, Inc. (001271188)
    Registrant - GW Laboratories, Inc. (001271188)
    Establishment
    Name Address ID/FEI Business Operations
    GW Laboratories, Inc. 001271188 MANUFACTURE
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