Betadine®

Betadine®
SPL v2
SPL
SPL Set ID 3007da5f-e2ea-4f3a-905c-770782da014e
Route
TOPICAL
Published
Effective Date 2025-02-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Iodine (100 mg)
Inactive Ingredients
Citric Acid Monohydrate Glycerin Polysorbate 80 Sodium Citrate, Unspecified Form Sodium Phosphate, Dibasic, Unspecified Form Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-01
Description

Povidone-iodine 10%

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Povidone-iodine 10%

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

Questions

1-833-288-2684



Dist. by: Atlantis Consumer

Healthcare Inc.

Bridgewater, NJ 08807 USA



©2024 Atlantis Consumer

Healthcare Inc.

Directions
  • 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
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

Ask a doctor before use if you have

  • deep or puncture wounds
  • animal bites
  • serious wounds

Active Ingredient

Povidone-iodine 10%

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

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.

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

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

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

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

Structured Label Content

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

Antiseptic

Warnings

For external use only

Questions

1-833-288-2684



Dist. by: Atlantis Consumer

Healthcare Inc.

Bridgewater, NJ 08807 USA



©2024 Atlantis Consumer

Healthcare Inc.

Directions
  • 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
Do Not Use (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

Ask a doctor before use if you have

  • deep or puncture wounds
  • animal bites
  • serious wounds

Active Ingredient (Active ingredient)

Povidone-iodine 10%

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

When Using This Product (When using this product)
  • prolonged exposure may cause irritation or, rarely, severe skin reactions
Stop Use and Ask A Doctor (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. (Keep out of reach of children.)

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

Package Label.principal Display Panel (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

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

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

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

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Source: dailymed · Ingested: 2026-02-15T12:06:24.759535 · Updated: 2026-03-14T23:09:10.710567