FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE solution/ drops

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BENOXINATE HYDROCHLORIDE (UNII: 0VE4U49K15) (BENOXINATE - UNII:AXQ0JYM303), FLUORESCEIN SODIUM (UNII: 93X55PE38X) (FLUORESCEIN - UNII:TPY09G7XIR)

Available from:

Bausch & Lomb Incorporated

INN (International Name):

BENOXINATE HYDROCHLORIDE

Composition:

BENOXINATE HYDROCHLORIDE 4 mg in 1 mL

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

For procedures requiring a disclosing agent in combination with a topical ophthalmic anesthetic agent such as tonometry, gonioscopy, removal of corneal foreign bodies and other short corneal or conjunctival procedures. Known hypersensitivity to any component of this product. Prolonged use of a topical ocular anesthetic is not recommended. It may produce permanent corneal opacification with accompanying visual loss.

Product summary:

Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution USP, 0.25%/0.4% is supplied in a glass bottle with a sterilized dropper in the following size: 5 mL – NDC 24208-732-05 Store in a refrigerator at 2°-8°C (36°-46°F). User may store at room temperature up to one month. Keep tightly closed. DO NOT USE IF IMPRINTED BODY SEAL IS NOT INTACT. KEEP OUT OF REACH OF CHILDREN. Revised: November 2012 Bausch & Lomb Incorporated Tampa, FL 33637 ©Bausch & Lomb Incorporated 9117602 (Folded) 9117702 (Flat) Prod. No. 30107

Authorization status:

unapproved drug other

Summary of Product characteristics

FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE- FLUORESCEIN SODIUM
AND
BENOXINATE HYDROCHLORIDE SOLUTION/ DROPS
BAUSCH & LOMB INCORPORATED
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE OPHTHALMIC SOLUTION
USP, 0.25%/0.4%
(STERILE)
RX ONLY
FOR USE IN THE EYES ONLY
DESCRIPTION
Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution
USP, 0.25%/0.4% is a
disclosing agent with rapid anesthetic action and short duration.
Fluorescein sodium is represented by the following structural formula:
C
H Na O
Mol. Wt. 376.28
Chemical Name: Spiro (isobenzofuran-1 (3_H_),9'-(9_H_)
xanthene)-3-one, 3',6' dihydroxy-, disodium salt.
Benoxinate hydrochloride is represented by the following structural
formula:
C
H N O • HCl
Mol. Wt. 344.88
20
10
2
5
17
28
2
3
Chemical Name: 2-(Diethylamino) ethyl 4-amino-3-butoxybenzoate
monohydrochloride.
EACH ML CONTAINS: ACTIVES: Fluorescein Sodium 2.5 mg (0.25%),
Benoxinate Hydrochloride 4 mg
(0.4%); INACTIVES: Boric Acid, Povidone, Purified Water. Hydrochloric
Acid may be added to
adjust pH (4.3 – 5.3). PRESERVATIVE ADDED: Chlorobutanol 1%.
CLINICAL PHARMACOLOGY
Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution
USP, 0.25%/0.4% is the
combination of a disclosing agent with a rapidly acting anesthetic of
short duration.
INDICATIONS AND USAGE
For procedures requiring a disclosing agent in combination with a
topical ophthalmic anesthetic agent
such as tonometry, gonioscopy, removal of corneal foreign bodies and
other short corneal or
conjunctival procedures.
CONTRAINDICATIONS
Known hypersensitivity to any component of this product.
WARNINGS NOT FOR INJECTION- FOR TOPICAL OPHTHALMIC USE ONLY.
Prolonged use of a topical ocular anesthetic is not recommended. It
may produce permanent corneal
opacification with accompanying visual loss.
PRECAUTIONS
Fluorescein Sodium and Benox