Betadine

Manufacturer
Xttrium Laboratories, Inc.
Effective date
2025-05-14
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 20:39:03

Label at a glance#

ProductBetadine
Active ingredientPOVIDONE-IODINE
Label structure9 sections

Indications and uses

Patient pre-operative skin preparation ■ for preparation of the skin prior to surgery ■ helps reduce bacteria that potentially can cause skin infection

Dosage and administration

■ single use only ■ clean the operative site prior to surgery ■ apply product and allow to dry ■ may be covered with a sterile bandage

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Povidone-iodine, 10%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

Patient pre-operative skin preparation
■ for preparation of the skin prior to surgery
■ helps reduce bacteria that potentially can cause skin infection

Warnings

WARNINGS SECTION

For external use only
Do not use
■ in the eyes ■ if you are allergic to povidone-iodine or any
other ingredients in this preparation
When using this product
■ prolonge 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, sensitization, or allergic reaction occurs and lasts for 72 hours.
These may be signs of a serious condition.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

■ single use only ■ clean the operative site prior to surgery
■ apply product and allow to dry ■ may be covered with a sterile bandage

Other information

OTHER SAFETY INFORMATION

■ store in original container

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

Inactive Ingredient

INACTIVE INGREDIENT SECTION

citric acid, disodium phosphate, glycerin, nonoxynol-9, purified water, sodium hydroxide

Questions?

OTC - QUESTIONS SECTION

1-833-288-2684

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Betadine 10 DFBetadine 10 DF

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0116-0150BETADINE (10% POVIDONE-IODINE) LIQUID [XTTRIUM LABORATORIES, INC.]4Unmatched20250515_26305292-e421-0481-e063-6394a90a8235.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0116-01500116-0150-05, 0116-0150-01, 0116-0150-04, 0116-0150-09, 0116-0150-17

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 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
34004103-dcc2-511c-e063-6394a90a270d26305292-e421-0481-e063-6394a90a82352025-05-14WarningsExact identifier
spl id: 34004103-dcc2-511c-e063-6394a90a270d
spl set id: 26305292-e421-0481-e063-6394a90a8235

Reported adverse events (FAERS/openFDA)#

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