Betadine® Solution Swabstick

Betadine® Solution Swabstick
SPL v8
SPL
SPL Set ID 0707b259-52a4-4ae6-b176-d093865906e7
Route
TOPICAL
Published
Effective Date 2021-12-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Iodine (10 mg)
Inactive Ingredients
Sodium Hydroxide Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 1972-09-15 Until 2025-11-11
Description

Povidone-iodine Solution USP, 10% (equal to1% available iodine)

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Povidone-iodine Solution USP, 10% (equal to1% available iodine)

Uses
  • for preparation of the skin prior to surgery
  • helps reduce bacteria that can potentially cause skin infection
Section 51945-4

BetadineSwabsticks — 1 Swab

NDC: 67618-153-01

BetadineSwabsticks — 3 Swabs

67618-153-03

Warnings

For external use only

Directions
  • tear at slit; pull top of packette across, exposing endof swabstick
  • remove Betadine Solution Swabstick and apply as needed
  • use one time only
Other Information

store between 20˚-25˚C (68˚-77˚F).Avoid freezing and excessive heat above 40˚C (104˚F).

Inactive Ingredients

purified water, sodium hydroxide

Dist. by:

Avrio Health L.P.

Stamford, CT 06901-3431

Do Not Use This Product
  • in the eyes
  • if you are allergic to iodine or other product ingredients
Stop Using This Product
  • in rare instances of local irritation or sensitivity
  • if irritation and redness develop and continue for morethan 72 hours
When Using This Product
  • prolonged exposure may cause irritation or, rarely, severeskin reactions
Active Ingredient Purpose

Povidone-iodine Solution USP, 10% (equal to1% available iodine)

Keep Out of Reach Ofchildren.

Ifswallowed, get medical help or contact a Poison Control Center rightaway

Structured Label Content

Uses
  • for preparation of the skin prior to surgery
  • helps reduce bacteria that can potentially cause skin infection
Section 51945-4 (51945-4)

BetadineSwabsticks — 1 Swab

NDC: 67618-153-01

BetadineSwabsticks — 3 Swabs

67618-153-03

Purpose

Antiseptic

Warnings

For external use only

Directions
  • tear at slit; pull top of packette across, exposing endof swabstick
  • remove Betadine Solution Swabstick and apply as needed
  • use one time only
Other Information (Other information)

store between 20˚-25˚C (68˚-77˚F).Avoid freezing and excessive heat above 40˚C (104˚F).

Inactive Ingredients (Inactive ingredients)

purified water, sodium hydroxide

Dist. by:

Avrio Health L.P.

Stamford, CT 06901-3431

Do Not Use This Product (Do not use this product)
  • in the eyes
  • if you are allergic to iodine or other product ingredients
Stop Using This Product (Stop using this product)
  • in rare instances of local irritation or sensitivity
  • if irritation and redness develop and continue for morethan 72 hours
When Using This Product (When using this product)
  • prolonged exposure may cause irritation or, rarely, severeskin reactions
Active Ingredient Purpose (Active ingredient Purpose)

Povidone-iodine Solution USP, 10% (equal to1% available iodine)

Keep Out of Reach Ofchildren. (Keep out of reach ofchildren.)

Ifswallowed, get medical help or contact a Poison Control Center rightaway

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:07.606995 · Updated: 2026-03-14T23:13:35.542610