FDA.reportPublic FDA data

PSP Iodine tincture BP 2.5 first aid antiseptic

Manufacturer
RW Consumer Products Ltd
Effective date
2021-09-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:34:31

Label at a glance#

ProductPSP Iodine tincture BP 2.5 first aid antiseptic
Active ingredientIODINE, POTASSIUM IODIDE
Label structure7 sections

Dosage and administration

• Clean the affected area • Apply a small amount of this product on the area 1 to 3 times daily • May be covered with a sterile bandage • If bandaged, let dry first

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Iodine 2.5%

Potassium Iodide 2.5%

Purpose

OTC - PURPOSE SECTION

First Aid Antiseptic

Use

INDICATIONS & USAGE SECTION

  • first aid to help prevent the risk of infection in minor cuts, scrapes, and burns

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

  • in the eyes or apply over large areas of the body
  • longer than 1 week unless directed by a doctor

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

• deep or puncture wounds • animal bites • serious burns

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • the condition persists or gets worse

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

• Clean the affected area • Apply a small amount of this product on the area 1 to 3 times daily • May be covered with a sterile bandage • If bandaged, let dry first

Other Information

SPL UNCLASSIFIED SECTION

  • Store in a cool, dark place
  • Do not use if shrink band around cap is broken or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

Ethyl alcohol, purified water

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label10Label10

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
69612-01969612-019-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT
IODINE9679TC07X4ACTIB
POTASSIUM IODIDE1C4QK22F9JACTIM

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
e0e17b29-8567-e02b-e053-2995a90a3492cba71f0f-b3f9-60e6-e053-2995a90a86cf2022-06-07WarningsExact identifier
spl set id: cba71f0f-b3f9-60e6-e053-2995a90a86cf

Reported adverse events (FAERS/openFDA)#

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