Betadine 100 mg/mL
POVIDONE-IODINE · SOLUTION · Atlantis Consumer Healthcare, Inc.
Betadine is a topical antiseptic solution containing povidone-iodine that you can apply directly to the skin 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)
67618-190- Manufacturer
- Atlantis Consumer Healthcare, Inc.
- Strength
- 100 mg/mL
- Dosage Form
- SOLUTION
- Route
- TOPICAL
- Marketing Status
- Application #
- M003
- Drug Class
- Antiseptic [EPC]
- Marketing Start
- 07/01/2025
Recall History
Edge Pharma, LLC
Lack of Assurance of Sterility
Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Edge Pharma, LLC
Defective container; syringe content migrating past the seal of the plunger may cause a lack of assurance of sterility
AVRIO HEALTH L.P
Subpotent Drug
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.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
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 is a topical antiseptic solution containing povidone-iodine that you can apply directly to the skin 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 100 mg/mL?
The NDC (National Drug Code) for Betadine 100 mg/mL is 67618-190, listed by Atlantis Consumer Healthcare, Inc..
Other Povidone-iodine Brands
See all →- EVERLIT CARE PRODUCTS IODINE PREP PAD.54 g/183807-012
- Povidone Iodine Scrub7.5 g/100g34645-5502
- POVIDONE-IODINE10 mg/mL50332-0056
- Aplicare Povidone-iodine Scrub7.5 mg/mL52380-2802
- sterile10 g/100g59050-552
- TWO PVP-I SCRUB LARGE WINGED SPONGES100 mg/mL59050-754
- Povidone-Iodine Scrub Sterile75 mg/g63517-657
- Surgical Scrub Skin Cleanser75 mg/mL67326-351
- Antiseptic Povidone-lodine Prep Pad10 mg/g82996-006
- Swab Applicator Brushes 8.3% w/w Povidone-Iodine and 72.5% w/w Isopropyl Alcohol (IPA)725 mg/mL84128-009
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)