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#
Contacts and useful links#
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
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Betadine
- Povidone-Iodine
- C12-15 PARETH-9
- SODIUM HYDROXIDE
- WATER
- IODINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0116-0160 | 0116-0160-03 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| C12-15 PARETH-9 | H3ZIY6WP1R | IACT |
| SODIUM HYDROXIDE | 55X04QC32I | IACT |
| WATER | 059QF0KO0R | IACT |
| POVIDONE-IODINE | 85H0HZU99M | ACTIM |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 34006b87-28cd-4463-e063-6294a90a63c9 | 265add32-3227-e05a-e063-6394a90a7371 | 2025-05-15 | Warnings | 34006b87-28cd-4463-e063-6294a90a63c9 265add32-3227-e05a-e063-6394a90a7371 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
