Country: Ամերիկայի Միացյալ Նահանգներ
language: անգլերեն
source: NLM (National Library of Medicine)
FLUOCINOLONE ACETONIDE (UNII: 0CD5FD6S2M) (FLUOCINOLONE ACETONIDE - UNII:0CD5FD6S2M)
SOLUTECH PHARMACEUTICALS LLC
FLUOCINOLONE ACETONIDE
FLUOCINOLONE ACETONIDE 0.1 mg in 1 mL
PRESCRIPTION DRUG
Do not use if known hypersensitivity to any of the listed ingredients of any of the components included in the kit. Fluocinolone Acetonide Topical Solution is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of components of the preparation. Contraindicated in patients with known hypersensitivity to any of the listed ingredients. 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.
Store at 20°-25°C (68° to 77°F); Keep away from heat and flame. Protect from freezing. [See USP Controlled Room Temperature.] Fluocinolone Acetonide Topical Solution 0.01% 60 mL Bottle with applicator tip - NDC 52565-012-59 Store at room temperature 15° to 25°C (59° to 77°F); avoid freezing and excessive heat above 40°C (104°F).
New Drug Application Authorized Generic
XILAPAK- FLUOCINOLONE ACETONIDE SOLUTECH PHARMACEUTICALS LLC ---------- XILAPAK KIT (NDC 70350-5218-1) FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. Rx Only XILAPAK KIT DESCRIPTION XILAPAK IS SUPPLIED AS 3 COMPONENTS IN A _KIT_: - - - INDICATION AND USAGE For the management of hypertrophic tissues, keloid tissues, dermatitis and dermatoses. 1 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 FOR EXTERNAL USE ONLY. Avoid contact with eyes, lips or mucous membranes. Do not use on areas of broken skin. CONTRAINDICATIONS Do not use if known hypersensitivity to any of the listed ingredients of _any_ of the components included in the kit. PRECAUTIONS Stop use and ask a doctor if redness or irritation develops. Keep this and all other medications out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. PREGNANCY If pregnant or breast feeding, ask a health professional before use. Store at 20°-25°C (68° to 77°F); Keep away from heat and flame. Protect from freezing. [See USP FLUOCINOLONE ACETONIDE TOPICAL SOLUTION USP, 0.01% (NDC 52565-012-59), 60mL CETAPHIL CLEANSER (NDC 00299-3921-40), 4 fl oz SILICONE TAPE, 1 Roll, 5.5 yards 1 This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent disease. Controlled Room Temperature.] MANUFACTURED FOR: SOLUTECH PHARMACEUTICALS LLC PEORIA, AZ 85345 RX ONLY FLUOCINOLONE ACETONIDE TOPICAL SOLUTION USP, 0.01% RX ONLY 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[(methylethylid read_full_document