FDA.reportPublic FDA data

BETADINE ® Professional Solution Swabsticks Povidone-iodine 10% Drug Facts

Manufacturer
Atlantis Consumer Healthcare, Inc.
Effective date
2025-02-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:06:02

Label at a glance#

ProductBetadine
Active ingredientPOVIDONE-IODINE
Label structure13 sections

Dosage and administration

tear at notch remove applicator use only once As a first aid antiseptic: clean affected area apply 1 to 3 times daily may be covered with a sterile bandage if bandaged, let dry first For preoperative patient skin preparation: clean area apply to operative site using applicator then wait at least 30 seconds prior to surgery

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Povidone-iodine 10%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use(s)

INDICATIONS & USAGE SECTION

  • for preparation of the skin prior to surgery
  • first aid to help prevent infection in minor cuts, scrapes, and burns

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • 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

Ask a doctor before use if you have

  • deep or puncture wounds
  • animal bites
  • serious wounds

When using this product

OTC - WHEN USING SECTION

  • prolonged exposure may cause irritation or, rarely, severe skin reactions

Stop use and ask a doctor

OTC - STOP USE SECTION

  • if condition persists or gets worse
  • in rare instances of local irritation or sensitivity

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • tear at notch
  • remove applicator
  • use only once

As a first aid antiseptic:

  • clean affected area
  • apply 1 to 3 times daily
  • may be covered with a sterile bandage
  • if bandaged, let dry first

For preoperative patient skin preparation:

  • clean area
  • apply to operative site using applicator then wait at least 30 seconds prior to surgery

Other Information

HOW SUPPLIED SECTION

  • store at room temperature 15°-30°C (59°-86°F)
  • avoid excessive heat

Inactive Ingredients

INACTIVE INGREDIENT SECTION

citric acid, glycerin, polysorbate 80 (tween 80), sodium citrate USP, sodium phosphate dibasic, water

Questions

OTC - QUESTIONS SECTION

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
Carton 50

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
Pouch

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
Carton 25

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67618-190-01Betadine1 in 1 POUCHSOLUTION12
67618-190-01Betadine1.9 mL in 1 APPLICATORSOLUTION1.92
67618-190-03Betadine1.9 mL in 1 APPLICATORSOLUTION1.92
67618-190-03Betadine3 in 1 POUCHSOLUTION32
67618-190-25Betadine3 in 1 PACKETSOLUTION32
67618-190-25Betadine25 in 1 BOXSOLUTION252
67618-190-50Betadine1 in 1 PACKETSOLUTION12
67618-190-50Betadine50 in 1 BOXSOLUTION502

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67618-190-25EA - Each67618-1900bf92667-b690-4063-9a13-048a3b4edb1112025-09-12
67618-190-50EA - Each67618-190cf9bbafa-9097-4594-85d6-91309108550d12025-09-12

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67618-19067618-190-01, 67618-190-03, 67618-190-50, 67618-190-25

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
POVIDONE-IODINE85H0HZU99MACTIM
Citric Acid Monohydrate2968PHW8QPIACT
GlycerinPDC6A3C0OXIACT
Polysorbate 806OZP39ZG8HIACT
Sodium Citrate, Unspecified Form1Q73Q2JULRIACT
Sodium Phosphate, Dibasic, Unspecified FormGR686LBA74IACT
Water059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BetadinePOVIDONE-IODINEAtlantis Consumer Healthcare, Inc.3007da5f-e2ea-4f3a-905c-770782da014e2025-02-14WarningsExact identifier
ndc (package): 67618-190-50
ndc (package): 67618-190-03
ndc (package): 67618-190-01
ndc (package): 67618-190-25
ndc (product): 67618-190
ndc11 (package): 67618019003
ndc11 (package): 67618019001
ndc11 (package): 67618019025
ndc11 (package): 67618019050
spl id: 73caf02a-cf17-4097-a1ee-6c3abe87103d
spl set id: 3007da5f-e2ea-4f3a-905c-770782da014e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.