Betadine
povidone-iodine · Solution · Topical, Ophthalmic
Uses
INDICATIONS AND USAGE: BETADINE* 5% Sterile Ophthalmic Prep Solution for the eye is indicated for prepping of the periocular region (lids, brow, and cheek) and irrigation of the ocular surface (cornea, conjunctiva, and palpebral fornices).
Warnings
WARNINGS: FOR EXTERNAL USE ONLY. NOT FOR INTRAOCULAR INJECTION OR IRRIGATION.
Dosage and administration
DOSAGE AND ADMINISTRATION: While the inner surface and contents of the immediate container (i.e. bottle) are sterile, the outer surface of the bottle is not sterile. The use of the bottle in a sterile field should be avoided. BETADINE* 5% Sterile Ophthalmic Prep Solution is used as follows: BETADINE* 5% Sterile Ophthalmic Prep Solution is used as follows: Make sure container is intact before use. To open, COMPLETELY TWIST OFF TAB, do not pull off. Gently pour entire contents of bottle into a sterile prep cup. Saturate sterile cotton-tipped applicator to prep lashes and lid margins using one or more applicators per lid; repeat once. Saturate sterile prep sponge or other suitable material to prep lids, brow and cheek in a circular ever-expanding fashion until the entire field is covered; repeat prep three (3) times. While separating the lids, irrigate the cornea, conjunctiva and palpebral fornices with BETADINE* 5% Sterile Ophthalmic Prep Solution using a sterile bulb syringe. After the BETADINE* 5% Sterile Ophthalmic Prep Solution has been left in contact for two minutes, sterile saline solution in a bulb syringe should be used to flush the residual prep solution from the cornea, conjunctiva, and the palpebral fornices.
Label text from the FDA structured product label by Alcon Laboratories, Inc. (revised Jun 29, 2022). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Povidone-iodine in 7 products
Betadine NDC products (7)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 0065-0411 | Povidone-iodine 5 mg/mL Solution | Alcon Laboratories, Inc. | NDA |
| 67618-150 | Povidone-iodine 10 mg/mL Solution | Atlantis Consumer Healthcare, Inc. | OTC MONOGRAPH DRUG |
| 67618-151 | Povidone-iodine .075 mg/mL Solution | Atlantis Consumer Healthcare, Inc. | OTC MONOGRAPH DRUG |
| 67618-153 | Povidone-iodine 10 mg/mL Solution | Atlantis Consumer Healthcare, Inc. | OTC MONOGRAPH DRUG |
| 67618-160 | Povidone-iodine 5 mg/mL Spray | Atlantis Consumer Healthcare, Inc. | OTC MONOGRAPH DRUG |
| 67618-190 | Povidone-iodine 100 mg/mL Solution | Atlantis Consumer Healthcare, Inc. | OTC MONOGRAPH DRUG |
| 67618-192 | Povidone-iodine 5 mg/mL Spray | Atlantis Consumer Healthcare, Inc. | OTC MONOGRAPH DRUG |
Betadine recalls
- D-1008-2022 Jun 15, 2022 · Class II · Terminated
cGMP deviations: Temperature abuse - D-0828-2021 Sep 29, 2021 · Class II · Terminated
Subpotent Drug - D-0070-2018 Nov 15, 2017 · Class II · Terminated
Subpotent Drug: The laminate used to make the pouches was reversed such that the aluminum layer was in contact with the product causing an exothermic reaction between the free iodine and the aluminum.
Frequently asked questions
What is Betadine used for?
INDICATIONS AND USAGE: BETADINE* 5% Sterile Ophthalmic Prep Solution for the eye is indicated for prepping of the periocular region (lids, brow, and cheek) and irrigation of the ocular surface (cornea, conjunctiva, and palpebral fornices).
Who makes Betadine?
Betadine is listed by 2 labelers in the FDA NDC directory, including Alcon Laboratories, Inc., Atlantis Consumer Healthcare, Inc..
Has Betadine been recalled?
The FDA enforcement database lists 3 recalls for Betadine, most recently D-1008-2022 (class ii): cGMP deviations: Temperature abuse