5% Betadine Spray 3oz

Manufacturer
Xttrium Laboratories, Inc.
Effective date
2025-05-15
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

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Povidone-iodine, 5%

OTC - PURPOSE SECTION

First aid antiseptic

INDICATIONS & USAGE SECTION

first aid to help prevent infection in minor
■ cuts ■ scrapes ■ burns

WARNINGS SECTION

Warnings For external use only
Do not use ■ in the eyes ■ over large areas of the body ■ if you are
allergic to povidone-iodine or any other ingredients in this preparation
Ask a doctor before use if you have ■ deep or puncture wounds
■ serious burns ■ animal bites
Stop use and ask a doctor if ■ the condition persists or gets worse
■ you need to use this product for more than 1 week

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

DOSAGE & ADMINISTRATION SECTION

■ clean the affected area
■ spray a small amount
of product on the area 1 to 3 times daily
■ may be covered with a sterile bandage
■ if bandaged, let dry first

OTHER SAFETY INFORMATION

■ store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) Do Not Freeze

INACTIVE INGREDIENT SECTION

pareth 25-9, purified water, sodium hydroxide

OTC - QUESTIONS SECTION

1-833-288-2684

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Betadine 3 OZBetadine 3 OZ

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0116-0160BETADINE (POVIDONE-IODINE) LIQUID [XTTRIUM LABORATORIES, INC.]2Unmatched20250519_265add32-3227-e05a-e063-6394a90a7371.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0116-01600116-0160-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 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
34006b87-28cd-4463-e063-6294a90a63c9265add32-3227-e05a-e063-6394a90a73712025-05-15WarningsExact identifier
spl id: 34006b87-28cd-4463-e063-6294a90a63c9
spl set id: 265add32-3227-e05a-e063-6394a90a7371

Reported adverse events (FAERS/openFDA)#

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