Drugplain

Betadine 5 mg/mL

POVIDONE-IODINE · SPRAY · Atlantis Consumer Healthcare, Inc.

5 Recalls on Record
Plain English

Betadine spray is a topical antiseptic containing povidone-iodine that you can buy without a prescription to help prevent infection in minor cuts, scrapes, and wounds. It works by killing bacteria and other microorganisms on the skin surface.

Key Facts

Brand Name
Betadine
Generic Name
POVIDONE-IODINE
NDC Code (Product)
67618-160
Manufacturer
Atlantis Consumer Healthcare, Inc.
Strength
5 mg/mL
Dosage Form
SPRAY
Route
TOPICAL
Marketing Status
Application #
M003
Drug Class
Antiseptic [EPC]
Marketing Start
04/15/1992

Recall History

5 Recalls on Record
Class II12/06/2021

Edge Pharma, LLC

Lack of Assurance of Sterility

TerminatedVoluntary: Firm initiated
Class II04/13/2022

Mckesson Medical-Surgical Inc. Corporate Office

cGMP deviations: Temperature abuse

TerminatedVoluntary: Firm initiated
Class II04/12/2021

Edge Pharma, LLC

Defective container; syringe content migrating past the seal of the plunger may cause a lack of assurance of sterility

TerminatedVoluntary: Firm initiated
Class II08/26/2021

AVRIO HEALTH L.P

Subpotent Drug

TerminatedVoluntary: Firm initiated
Class II10/05/2017

Purdue Pharma, LP

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.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

off label use486 reports
drug hypersensitivity469 reports
endophthalmitis372 reports
drug ineffective351 reports
rash272 reports
toxic anterior segment syndrome244 reports
nausea227 reports
pain224 reports
arthralgia216 reports
condition aggravated206 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses First aid to help prevent infection in minor cuts scrapes burns

Dosage & Administration

Directions clean the affected area spray a small amount of the product on the area 1 to 3 times daily may be covered with a sterile bandage if bandaged, let dry first

Warnings

Warnings For external use only

Frequently Asked Questions

What is Betadine used for?

Betadine spray is a topical antiseptic containing povidone-iodine that you can buy without a prescription to help prevent infection in minor cuts, scrapes, and wounds. It works by killing bacteria and other microorganisms on the skin surface.

Is Betadine a controlled substance?

Betadine is not classified as a controlled substance by the DEA.

What is the generic name for Betadine?

The generic name for Betadine is POVIDONE-IODINE. There are 12 other brand versions of POVIDONE-IODINE.

What is the NDC code for Betadine 5 mg/mL?

The NDC (National Drug Code) for Betadine 5 mg/mL is 67618-160, listed by Atlantis Consumer Healthcare, Inc..