Betadine

Manufacturer
Xttrium Laboratories, Inc.
Effective date
2025-05-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 20:38:58

Label at a glance#

ProductBetadine
Active ingredientPOVIDONE-IODINE
Label structure9 sections

Indications and uses

■ for preparation of the skin prior to surgery ■ helps to reduce bacteria that potentially can cause skin infection ■ for handwashing to reduce bacteria on the skin ■ significantly reduces the number of microorganisms on the hands forearms prior to surgery or patient care

Dosage and administration

A. 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 B. Antiseptic hand wash: wet hands w...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Povidone-Iodine, 7.5%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION


■ for preparation of the skin prior to surgery
■ helps to reduce bacteria that potentially can cause skin infection
■ for handwashing to reduce bacteria on the skin
■ significantly reduces the number of microorganisms on the hands forearms prior to surgery or patient care

Warnings

WARNINGS SECTION

For external use only
Do not use
■ in the eyes
When using this product ■ prolonged exposure to wet solution may cause irritation or, rarely, severe skin reactions
■ in pre-operative prepping, avoid "pooling" beneath the patient
Stop use and ask a doctor ■ if irritation and redness develop
■ in rare instances of local irritation or sensitivity

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

A. 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

B. 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

C. Patient pre-operative skin preparation:
■ single use only

■ wet skin with water
■ apply Scrub (1 cc is sufficient to cover an area of 20-30 square inches),
develop lather and scrub thoroughly for about 5 minutes
■ rinse off using sterile gauze saturated with water
■ the area may then be painted with BETADINE Solution and allowed to dry

OTHER SAFETY INFORMATION

■ store at 25'C (77'F); excursions permitted between 15'-30'C (59'-86'F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

1-833-288-2684

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Betadine 4 OZBetadine 4 OZBetadine GallonBetadine Gallon

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0116-0151BETADINE (POVIDONE-IODINE) LIQUID [XTTRIUM LABORATORIES, INC.]2Unmatched20250519_26573a6d-2e4a-3841-e063-6294a90a291a.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0116-01510116-0151-04, 0116-0151-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
3400700c-0850-7944-e063-6294a90a2aa826573a6d-2e4a-3841-e063-6294a90a291a2025-05-14WarningsExact identifier
spl id: 3400700c-0850-7944-e063-6294a90a2aa8
spl set id: 26573a6d-2e4a-3841-e063-6294a90a291a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.