Betadine® Solution

Betadine® Solution
SPL v8
SPL
SPL Set ID 1b1e224c-8c00-46ea-9bdd-020a9b45321d
Route
TOPICAL
Published
Effective Date 2023-12-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Iodine (10 mg)
Inactive Ingredients
Citric Acid Monohydrate Sodium Phosphate, Dibasic, Monohydrate Glycerin Nonoxynol-9 Water Sodium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 1980-06-01
Description

Active ingredient Povidone-iodine, 10% (1% available iodine)

Purpose

First aid antiseptic

Medication Information

Purpose

First aid antiseptic

Description

Active ingredient Povidone-iodine, 10% (1% available iodine)

Uses

First aid to helpprevent infection in minor

  • cuts
  • scrapes
  • burns
Section 42229-5

Dist.by:

Avrio Health L.P.

Stamford, CT 06901-3431

305541-0D

Section 50565-1

Keep out of reach of children.

If swallowed, getmedical help or contact a Poison Control Center right away

Section 51945-4

BetadineSolution 8 fl oz Bottle

NDC: 67618-150-08

Directions
  • clean the affected area
  • apply a small amount of product to the area 1 to 3 timesdaily
  • may be covered with a sterile bandage
  • if bandaged, let dry first
Do Not Use
  • in the eyes
  • over large areas of the body
  • if you are allergic to povidone-iodine or any other ingredientsin this preparation
Drug Facts

Active ingredient

Povidone-iodine, 10% (1% available iodine)

Other Information
  • store at 25°C (77°F); excursions permitted between 15°-30°C(59°-86°F)
Inactive Ingredients

citric acid, disodiumphosphate, glycerin, nonoxynol-9, purified water, sodium hydroxide

Stop Use and Ask A Doctor If
  • the condition persists or gets worse
  • you need to use this product for more than 1 week
Ask A Doctor Before Useif You Have
  • deep or puncture wounds
  • serious burns
  • animal bites

Structured Label Content

Uses

First aid to helpprevent infection in minor

  • cuts
  • scrapes
  • burns
Section 42229-5 (42229-5)

Dist.by:

Avrio Health L.P.

Stamford, CT 06901-3431

305541-0D

Section 50565-1 (50565-1)

Keep out of reach of children.

If swallowed, getmedical help or contact a Poison Control Center right away

Section 51945-4 (51945-4)

BetadineSolution 8 fl oz Bottle

NDC: 67618-150-08

Purpose

First aid antiseptic

Directions
  • clean the affected area
  • apply a small amount of product to the area 1 to 3 timesdaily
  • may be covered with a sterile bandage
  • if bandaged, let dry first
Do Not Use (Do not use)
  • in the eyes
  • over large areas of the body
  • if you are allergic to povidone-iodine or any other ingredientsin this preparation
Drug Facts

Active ingredient

Povidone-iodine, 10% (1% available iodine)

Other Information (Other information)
  • store at 25°C (77°F); excursions permitted between 15°-30°C(59°-86°F)
Inactive Ingredients (Inactive ingredients)

citric acid, disodiumphosphate, glycerin, nonoxynol-9, purified water, sodium hydroxide

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • the condition persists or gets worse
  • you need to use this product for more than 1 week
Ask A Doctor Before Useif You Have (Ask a doctor before useif you have)
  • deep or puncture wounds
  • serious burns
  • animal bites

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:20.432525 · Updated: 2026-03-14T23:12:34.529887