Betadine® Solution

Betadine® Solution
SPL v11
SPL
SPL Set ID 41891599-420e-48d2-8e31-d28a2209e383
Route
TOPICAL
Published
Effective Date 2020-11-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Iodine (10 mg)
Inactive Ingredients
Water Sodium Hydroxide C12-15 Pareth-9

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 1980-06-01 Until 2025-07-31
Description

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

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

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

Uses

Patient pre-operative skin preparation

  • for preparation of the skin prior to surgery
  • helps reduce bacteria that potentially can cause skin infection
Section 42229-5

Dist. by:

Avrio Health L.P.

Stamford, CT 06901-3431

©2018, Avrio Health L.P.

Section 50565-1

Keep out of reach of children.

If swallowed, get medical help or contact a Poison ControlCenter right away.

Section 51945-4

BetadineSolution 8 oz

NDC: 67618-150-09

Warnings

For external use only

Directions
  • single use may prevent extrinsic contamination
  • clean the operative site prior to surgery
  • apply product and allow to dry
  • may be covered with a bandage
Do Not Use
  • in the eyes
  • 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 in original container
  • store at 25°C (77°F); excursions permitted between 15°-30°C(59°-86°F)
Inactive Ingredients

pareth 25-9, purified water, sodium hydroxide

When Using This Product
  • single use will reduce the risk of infection from extrinsiccontamination
  • prolonged exposure to wet solution may cause irritationor, rarely, severe skin reactions
  • in pre-operative prepping, avoid “pooling” beneath the patient
Stop Use and Ask A Doctorif
  • irritation, sensitization, or allergic reaction occurs andlasts for 72 hours. These may be signs of a serious condition.

Structured Label Content

Uses

Patient pre-operative skin preparation

  • for preparation of the skin prior to surgery
  • helps reduce bacteria that potentially can cause skin infection
Section 42229-5 (42229-5)

Dist. by:

Avrio Health L.P.

Stamford, CT 06901-3431

©2018, Avrio Health L.P.

Section 50565-1 (50565-1)

Keep out of reach of children.

If swallowed, get medical help or contact a Poison ControlCenter right away.

Section 51945-4 (51945-4)

BetadineSolution 8 oz

NDC: 67618-150-09

Purpose

Antiseptic

Warnings

For external use only

Directions
  • single use may prevent extrinsic contamination
  • clean the operative site prior to surgery
  • apply product and allow to dry
  • may be covered with a bandage
Do Not Use (Do not use)
  • in the eyes
  • 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 in original container
  • store at 25°C (77°F); excursions permitted between 15°-30°C(59°-86°F)
Inactive Ingredients (Inactive ingredients)

pareth 25-9, purified water, sodium hydroxide

When Using This Product (When using this product)
  • single use will reduce the risk of infection from extrinsiccontamination
  • prolonged exposure to wet solution may cause irritationor, rarely, severe skin reactions
  • in pre-operative prepping, avoid “pooling” beneath the patient
Stop Use and Ask A Doctorif (Stop use and ask a doctorif)
  • irritation, sensitization, or allergic reaction occurs andlasts for 72 hours. These may be signs of a serious condition.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:13.636916 · Updated: 2026-03-14T23:06:44.003626