Label: FLURESS- fluorescein sodium and benoxinate hydrochloride solution/ drops
- NDC Code(s): 17478-640-10
- Packager: Akorn, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Updated January 5, 2012
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- SPL UNCLASSIFIED SECTION
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Fluress® (Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution, USP) is a sterile ophthalmic solution combining a disclosing agent with an anesthetic agent.
Fluorescein sodium is a disclosing agent with molecular formula C20H10Na2O5, molecular weight 376.28, and chemical structure:
Spiro[isobenzofuran-1 (3H), 9'-[9H]xanthene]-3-one. 3'6'-dihydroxy, Disodium salt
Benoxinate Hydrochloride is an anesthetic agent with molecular formula C17H28N2O3•HCl, molecular weight 344.88, and chemical structure:
Benzoic acid, 4-amino-3-butoxyl-,2-(diethylamino) ethyl ester, monohydrochloride
Each mL contains:
Actives: Benoxinate Hydrochloride 4 mg (0.4%). Fluorescein Sodium 2.5 mg (0.25%).
Preservative: Chlorobutanol 10 mg (1%).
Inactives: Boric Acid, Povidone, Sodium Hydroxide and/or Hydrochloric Acid may be added to adjust pH (4.3 to 5.3), and Purified Water USP.
- CLINICAL PHARMACOLOGY:
- INDICATIONS AND USAGE:
Fluress® (Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution, USP) should be used cautiously and sparingly in patients with known allergies, cardiac disease, or hyperthyroidism. The long-term toxicity is unknown; prolonged use may possibly delay wound healing. Although exceedingly rare with ophthalmic application of local anesthetics, systemic toxicity (manifested by central nervous system stimulation followed by depression) may occur.
Protection of the eye from irritating chemicals, foreign bodies and rubbing during the period of anesthesia is very important. Tonometers soaked in sterilizing or detergent solutions should be thoroughly rinsed with sterile distilled water prior to use. Patients should be advised to avoid touching the eye until the anesthesia has worn off.
Occasional temporary stinging, burning and conjunctival redness have been reported after use of ocular anesthetics, as well as a rare severe, immediate-type, apparently hyperallergic corneal reaction with acute, intense and diffuse epithelial keratitis, a gray, ground glass appearance, sloughing or large areas of necrotic epithelium, corneal filaments and sometimes, iritis with descemetitis.
Allergic contact dermatitis with drying and fissuring of the fingertips has been reported.
- DOSAGE AND ADMINISTRATION:
- HOW SUPPLIED:
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INGREDIENTS AND APPEARANCE
fluorescein sodium and benoxinate hydrochloride solution/ drops
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:17478-640 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Fluorescein Sodium (UNII: 93X55PE38X) (Fluorescein - UNII:TPY09G7XIR) Fluorescein Sodium 2.5 mg in 1 mL Benoxinate Hydrochloride (UNII: 0VE4U49K15) (Benoxinate - UNII:AXQ0JYM303) Benoxinate Hydrochloride 4 mg in 1 mL Inactive Ingredients Ingredient Name Strength Boric Acid (UNII: R57ZHV85D4) Povidone (UNII: FZ989GH94E) Sodium Hydroxide (UNII: 55X04QC32I) Hydrochloric Acid (UNII: QTT17582CB) WATER (UNII: 059QF0KO0R) Chlorobutanol (UNII: HM4YQM8WRC) 10 mg in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:17478-640-10 1 in 1 CARTON 02/01/1995 1 5 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 02/01/1995 Labeler - Akorn, Inc. (062649876) Establishment Name Address ID/FEI Business Operations Akorn, Inc. 155135783 MANUFACTURE(17478-640) , REPACK(17478-640) , ANALYSIS(17478-640) , LABEL(17478-640) , PACK(17478-640) , RELABEL(17478-640) , STERILIZE(17478-640)