FDA.reportPublic FDA data

First Aid Direct Povidone Iodine

Manufacturer
CINTAS CORPORATION | JAMES ALEXANDER CORP
Effective date
2024-12-27
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 20:44:07

Label at a glance#

ProductFirst Aid Direct Povidone Iodine
Active ingredientPOVIDONE-IODINE
Label structure12 sections

Indications and uses

To treat minor skin cuts, and abrasions

Dosage and administration

Reverse cardboard sleeve then crush at dot between thumb and forefinger. Allow  solution to saturate tip and apply solution to injury.

Label contents#

Full prescribing information#

Active Ingredients (each swab)

OTC - ACTIVE INGREDIENT SECTION

10% Povidone Iodine Solution USP (1% available iodine)

Purpose

OTC - PURPOSE SECTION

Topical Antiseptic

Uses

INDICATIONS & USAGE SECTION

To treat minor skin cuts, and abrasions

WARNINGS

WARNINGS SECTION

FOR EXTERNAL USE ONLY

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • deep or puncture wounds
  • serious burn

Stop use and ask doctor if

OTC - STOP USE SECTION

  • redness, irritation, swelling or pain persists or increases
  • infection occurs

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

Reverse cardboard sleeve then crush at dot between thumb and forefinger.

Allow solution to saturate tip and apply solution to injury.

Other Information

OTHER SAFETY INFORMATION

Store at room temperature away from light keep from freezing or excessive heat

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water

Questions?

OTC - QUESTIONS SECTION

Call 1-908-362-9266 Monday through Friday 9:00 am - 5:00 pm e.s.t.

Package Label Principal Display Panel - Box of 10 Swabs

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

10 SWABS

(1/2 ml.)

UNIT NO. 

U1-16A

POVIDONE - IODINE SWABS U.S.P.

(ANTISEPTIC)

CONTAINS: POVIDONE IODINE 10%

EQUIVALENT TO 1% AVAILABLE IODINE

DISTRIBUTED BY

first aid direct

Mason, OH 45040

cartoncarton

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42961-110FIRST AID DIRECT POVIDONE IODINE (POVIDONE IODINE ANTISEPTIC) SWAB [CINTAS CORPORATION]3Legacy NDC20241228_37d75e05-0af3-463b-a614-1fd0588b0f4e.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42961-11042961-110-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
POVIDONE-IODINE85H0HZU99MACTIM
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM PHOSPHATE, DIBASICGR686LBA74IACT
NONOXYNOL-948Q180SH9TIACT
SODIUM HYDRIDE23J3BHR95OIACT
WATER059QF0KO0RIACT

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
97c0c856-e808-4da3-a12b-47d6d4192b5837d75e05-0af3-463b-a614-1fd0588b0f4e2025-07-28WarningsExact identifier
spl set id: 37d75e05-0af3-463b-a614-1fd0588b0f4e

Reported adverse events (FAERS/openFDA)#

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