Betadine Surgical Scrub

Betadine Surgical Scrub
SPL v11
SPL
SPL Set ID 1ad39e11-ea1e-44a4-8224-93f8135436c2
Route
TOPICAL
Published
Effective Date 2020-12-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Iodine (.075 mg)
Inactive Ingredients
Ammonium Nonoxynol-4 Sulfate Nonoxynol-9 Water Sodium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 1996-07-01 Until 2024-11-30
Description

Drug Facts Active ingredient Povidone-iodine, 7.5%(0.75% available iodine)

Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Uses

  • helps to reduce bacteria that potentially can cause skininfection
  • for handwashing to reduce bacteria on the skin
  • significantly reduces the number of microorganisms on thehands and forearms prior to surgery or patient care
Dosage and Administration

Directions

  • Surgical hand scrub:
    • wet hands with water
    • spread about 5 cc (1 teaspoonful) of Scrub over both handsand forearms
    • without adding more water, scrub thoroughly for 2 1/2 to3 minutes
    • use a sponge if desired. Clean thoroughly under fingernails.
    • add a little water and develop copious suds. Rinse thoroughlyunder running water.
    • repeat the entire procedure using another 5 cc of Scrub
  • Antiseptic hand wash:
    • wet hands with water and pour about 5 cc of Scrub on hands
    • rub hands vigorously together for at least 15 seconds, coveringall surfaces
    • rinse and dry with a disposable towel
Description

Drug Facts Active ingredient Povidone-iodine, 7.5%(0.75% available iodine)

Section 42229-5

Dist. by:

AvrioHealth L.P. Stamford, CT 06901-3431

304954-0A

Section 44425-7

Other information

  • store at 25°C (77°F); excursions permitted between 15°-30°C(59°-86°F)
  • store in original container
Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50567-7

When using this product

  • prolonged exposure to wet solution may cause irritation or, rarely, severe skin reactions
Section 50569-3

Stop use and ask a doctor

  • if irritation and redness develop
  • in rare instances of local irritation or sensitivity
Section 50570-1

Do not use this product

  • in the eyes
Section 51727-6

Inactive ingredients

ammonium nonoxynol-4sulfate, nonoxynol-9, purified water, sodium hydroxide

Section 51945-4

Betadine Surgical Scrub

NDC 67618-151-17

Section 55105-1

Purpose

Antiseptic

Section 55106-9

Drug Facts



Active ingredient

Povidone-iodine, 7.5%(0.75% available iodine)

Structured Label Content

Indications and Usage (34067-9)

Uses

  • helps to reduce bacteria that potentially can cause skininfection
  • for handwashing to reduce bacteria on the skin
  • significantly reduces the number of microorganisms on thehands and forearms prior to surgery or patient care
Dosage and Administration (34068-7)

Directions

  • Surgical hand scrub:
    • wet hands with water
    • spread about 5 cc (1 teaspoonful) of Scrub over both handsand forearms
    • without adding more water, scrub thoroughly for 2 1/2 to3 minutes
    • use a sponge if desired. Clean thoroughly under fingernails.
    • add a little water and develop copious suds. Rinse thoroughlyunder running water.
    • repeat the entire procedure using another 5 cc of Scrub
  • Antiseptic hand wash:
    • wet hands with water and pour about 5 cc of Scrub on hands
    • rub hands vigorously together for at least 15 seconds, coveringall surfaces
    • rinse and dry with a disposable towel
Warnings and Precautions (34071-1)

Warnings

For external use only

Section 42229-5 (42229-5)

Dist. by:

AvrioHealth L.P. Stamford, CT 06901-3431

304954-0A

Section 44425-7 (44425-7)

Other information

  • store at 25°C (77°F); excursions permitted between 15°-30°C(59°-86°F)
  • store in original container
Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50567-7 (50567-7)

When using this product

  • prolonged exposure to wet solution may cause irritation or, rarely, severe skin reactions
Section 50569-3 (50569-3)

Stop use and ask a doctor

  • if irritation and redness develop
  • in rare instances of local irritation or sensitivity
Section 50570-1 (50570-1)

Do not use this product

  • in the eyes
Section 51727-6 (51727-6)

Inactive ingredients

ammonium nonoxynol-4sulfate, nonoxynol-9, purified water, sodium hydroxide

Section 51945-4 (51945-4)

Betadine Surgical Scrub

NDC 67618-151-17

Section 55105-1 (55105-1)

Purpose

Antiseptic

Section 55106-9 (55106-9)

Drug Facts



Active ingredient

Povidone-iodine, 7.5%(0.75% available iodine)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:13.582692 · Updated: 2026-03-14T23:06:42.095401