Fluocinolone Acetonide .11 mg/mL Oil, 1 bottle — NDC 71335-2883-1 (Billing 71335-2883-01)

ADVERSE REACTIONS The following local adverse reactions have been reported infrequently with topical corticosteroids. They may occur more frequently with the use of occlusive dressings, especially with higher potency corticosteroids. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, and miliaria.

One peanut sensitive child experienced a flare of his atopic dermatitis after 5 days of twice daily treatment with fluocinolone acetonide topical oil, 0.01%. A post marketing (open-label) safety study was conducted in 58 children to evaluate the local safety of fluocinolone acetonide topical oil, 0.01% when applied twice daily for 4 weeks to the face in children (2 to 12 years) with moderate to severe atopic dermatitis (see Table of Incidence of Adverse Events ). Incidence of Adverse Events (%) N=58 Adverse Event (AE) * # of patients (%) Day 14 Day 28 † D ay 56 ‡ * The number of individual adverse events reported does not necessarily reflect the number of individual subjects, since one subject could have multiple reporting of an adverse event. † End of Treat ment ‡ Four Weeks Post Treatment Any AE 15 (25.9) 6 (10.3) 7 (12.1) 7 (12.1) Telangiectasia 5 (8.6) 3 (5.2) 4 (6.9) 2 (3.5) Erythema 3 (5.2) 3 (5.2) Itching 3 (5.2) 3 (5.2) Irritation 3 (5.2) 3 (5.2) Burning 3 (5.2) 3 (5.2) Hypopigmentation 2 (3.5) 2 (3.5) Shiny skin 1 (1.7) 1 (1.7) Secondary atopic dermatitis 1 (1.7) 1 (1.7) Papules and pustules 1 (1.7) 1 (1.7) Keratosis pilaris 1 (1.7) 1 (1.7) Folliculitis 1 (1.7) 1 (1.7) Facial herpes simplex 1 (1.7) 1 (1.7) Acneiform eruption 1 (1.7) 1 (1.7) Ear infection 1 (1.7) 1 (1.7) To report SUSPECTED ADVERSE REACTIONS, contact Quagen Pharmaceuticals LLC at 1-888-344-9603 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

PRECAUTIONS General: Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary- adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Manifestations of Cushing's syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment. Patients applying a topical steroid to a large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA axis suppression.

This may be done by using the ACTH stimulation, A.M. plasma cortisol, and urinary free cortisol 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 corticosteroid. Infrequently, signs and symptoms of glucocorticoid insufficiency may occur requiring supplemental systemic corticosteroids.

For information on systemic supplementation, see prescribing information for those products. Children may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios. (see PRECAUTIONS-Pediatric use ) Allergic contact dermatitis to any component of topical corticosteroids is usually diagnosed by a failure to heal rather than noting a clinical exacerbation, which may occur with most topical products not containing corticosteroids.

Such an observation should be corroborated with appropriate diagnostic testing. One peanut sensitive child experienced a flare of his atopic dermatitis after 5 days of twice daily treatment with fluocinolone acetonide topical oil, 0.01% (see CLINICAL STUDIES section). If wheal and flare type reactions (which may be limited to pruritus) or other manifestations of hypersensitivity develop, fluocinolone acetonide topical oil, 0.01% should be discontinued immediately and appropriate therapy instituted.

If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent should be used. If a favorable response does not occur promptly, use of fluocinolone acetonide topical oil, 0.01% should be discontinued until the infection has been adequately controlled. Fluocinolone acetonide topical oil, 0.01% is formulated with 48% refined peanut oil NF.

Physicians should use caution in prescribing fluocinolone acetonide topical oil, 0.01% for peanut sensitive individuals. Information for Patients: 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. In case of contact, wash eyes liberally with water.

2. This medication should not be used for any disorder other than that for which it was prescribed. 3.

Patients should promptly report to their physician any worsening of their skin condition. 4. Parents of pediatric patients should be advised not to use fluocinolone acetonide topical oil, 0.01% in the treatment of diaper dermatitis.

Fluocinolone acetonide topical oil, 0.01% should not be applied to the diaper area as diapers or plastic pants may constitute occlusive dressing. 5. This medication should not be used on the face, underarm, or groin unless directed by the physician.

6. As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, contact the physician.

Laboratory Tests: The following tests may be helpful in evaluating patients for HPA axis suppression: ACTH stimulation test A.M. plasma cortisol test Urinary free cortisol 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 fluocinolone acetonide topical oil, 0.01%. Studies have not been performed to evaluate the mutagenic potential of fluocinolone acetonide, the active… [Excerpted — this section continues on DailyMed.]