Active Ingredient
Povidone-iodine 10%
Betadine Solution
FDA Label NDC 67618-190
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Atlantis Consumer Healthcare, Inc. for the product Betadine (NDC 67618-190). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, use(s), warnings, do not use, when using this product, stop use and ask a doctor, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antiseptic
Use(S)
- for preparation of the skin prior to surgery
- first aid to help prevent infection in minor cuts, scrapes, and burns
Warnings
For external use only
Do Not Use
- in the eyes or over large areas of the body
- longer than 1 week unless directed by a doctor
- if you are allergic to iodine or other product ingredients
- deep or puncture wounds
- animal bites
- serious wounds
Ask a doctor before use if you have
When Using This Product
- prolonged exposure may cause irritation or, rarely, severe skin reactions
Stop Use And Ask A Doctor
- if condition persists or gets worse
- in rare instances of local irritation or sensitivity
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
- tear at notch
- remove applicator
- use only once
- clean affected area
- apply 1 to 3 times daily
- may be covered with a sterile bandage
- if bandaged, let dry first
- clean area
- apply to operative site using applicator then wait at least 30 seconds prior to surgery
As a first aid antiseptic:
For preoperative patient skin preparation:
Other Information
- store at room temperature 15°-30°C (59°-86°F)
- avoid excessive heat
Inactive Ingredients
citric acid, glycerin, polysorbate 80 (tween 80), sodium citrate USP, sodium phosphate dibasic, water
Questions
1-833-288-2684
Dist. by: Atlantis Consumer
Healthcare Inc.
Bridgewater, NJ 08807 USA
©2024 Atlantis Consumer
Healthcare Inc.
Package Label.Principal Display Panel
NDC 67618-190-01
BETADINE®
SOLUTION
Swabsticks
Povidone-iodine 10%
To Open Tear At Slit
Antiseptic Non-Sterile
Solution
Contains 1 Single-Use,
Disposable Swabstick
Do not use if package
is damaged or open.
Not Labeled for
Consumer Use
For Professional
and Hospital
Use Only
A1224
Dist. by: Atlantis Consumer
Healthcare Inc.
Bridgewater, NJ 08807 USA
See box for complete Drug Facts
©2024 Atlantis Consumer
Healthcare Inc.
Questions? 1-833-288-2684
Pouch (Pouch)
NDC 67618-190-50
For Professional and Hospital Use Only
BETADINE®
SOLUTION
Swabsticks
Povidone-iodine 10%
Antiseptic Non-Sterile
Solution
50
Single-use, Disposable
Swabsticks
1 saturated swab per packet
LOT LLLLLLLLLLLL
EXP YYYY-MM-DD
Carton 50 (Carton50)
NDC 67618-190-03
BETADINE®
SOLUTION
Swabsticks
Povidone-iodine 10%
To Open Tear At Slit
Antiseptic Non-Sterile
Solution
Contains 3 Single-Use,
Disposable Swabstick
Do not use if package is damaged or open.
For Professional and Hospital Use Only
Not Labeled for Consumer Use
See box for complete Drug Facts
Dist. by: Atlantis Consumer Healthcare Inc.
Bridgewater, NJ 08807 USA
A1224
©2024 Atlantis Consumer Healthcare Inc.
Questions? 1-833-288-2684
Pouch (Pouch2)
NDC 67618-190-25
For Professional and Hospital Use Only
BETADINE®
SOLUTION
Swabsticks
Povidone-iodine 10%
Antiseptic Non-Sterile
Solution
25
Single-use, Disposable
Swabsticks
3 saturated swabs per packet
LOT LLLLLLLLLLLL
EXP YYYY-MM-DD
Carton 25 (Carton25)
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