Povidone Iodine Gel Swabstick

Manufacturer
Dynarex Corporation
Effective date
2024-02-13
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:08:37

Label at a glance#

ProductPovidone Iodine Gel Swabstick
Active ingredientPOVIDONE-IODINE
Label structure9 sections

Dosage and administration

• Tear at notch • Remove applicator • Use only once As a first aid antiseptic: • Clean affected area • Apply 1 to 3 times daily • May be covered with a sterile bandage • If bandaged, let dry first For preoperative patient skin preparation: • Clean area • Apply to operative site prior to surgery For Venipuncture skin preparation: • Hold the swabstick at an angle and begin scrubbing in a circular motion over a 1-inc...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Povidone-Iodine 10%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use(s)

INDICATIONS & USAGE SECTION

• For preparation of the skin prior to surgery

• First aid to help prevent infection in minor cuts, scrapes, and burns

• For venipuncture skin preparation

Warnings

WARNINGS SECTION

For External Use Only

Do not use

OTC - DO NOT USE SECTION

• In the eyes or 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

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 (800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• Tear at notch • Remove applicator • Use only once

As a first aid antiseptic:

• Clean affected area

• Apply 1 to 3 times daily

• May be covered with a sterile bandage

• If bandaged, let dry first

For preoperative patient skin preparation:

• Clean area

• Apply to operative site prior to surgery

For Venipuncture skin preparation:

• Hold the swabstick at an angle and begin scrubbing in a circular motion over a 1-inch area, directly over the venipuncture site. Continue this for a minimum of 30 seconds.

• After scrubbing for 30 seconds, and using the same applicator, begin at the venipuncture site and move gradually outward in concentric circles to form a total prepped area measuring at least 3 inches in diameter.

• Allow site to dry for approximately 30 seconds.

• If the patient bend the arm, or if prepared site is touched with the fingers or with any other non-sterile object, the complete preparation must be repeated.

Other Information

OTHER SAFETY INFORMATION

• Store at room temperature 15º-30ºC (59º-86ºF)

• Avoid excessive heat

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Demineralized Water, Disodium Phosphate Anhydrous, Glycerin, Natrozole HHR

Questions and Comments?

OTC - QUESTIONS SECTION

1-888-369-2739 M-F, 9-5 EST

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1209 BX MASTER1209 BX MASTER1209 Povidone-Iodine Gel Swabstick

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
312562povidone-iodine 10 % Topical GelPSN4
312562povidone-iodine 0.1 MG/MG Topical GelSCD4
312562povidone-iodine 10 % (titratable iodine 1 % ) Topical GelSY4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67777-418-01Povidone Iodine Gel Swabstick10 in 1 CASEGEL104
67777-418-02Povidone Iodine Gel Swabstick50 in 1 BOXGEL504
67777-418-02Povidone Iodine Gel Swabstick0.3 mL in 1 PACKETGEL0.34

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67777-418POVIDONE IODINE GEL SWABSTICK GEL [DYNAREX CORPORATION]4Current NDC, Legacy NDC, 3 package rows20240214_eb7e21be-521e-2d52-e053-2a95a90ade33.zip

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
67777-41867777-418-02, 67777-418-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 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
Povidone Iodine Gel SwabstickPOVIDONE IODINE GEL SWABSTICKDynarex Corporationeb7e21be-521e-2d52-e053-2a95a90ade332024-02-13WarningsExact identifier
ndc (package): 67777-418-01
ndc (package): 67777-418-02
ndc (product): 67777-418
ndc11 (package): 67777041801
ndc11 (package): 67777041802
spl id: 11494162-dcc4-6f7d-e063-6294a90ad91f
spl set id: eb7e21be-521e-2d52-e053-2a95a90ade33

Reported adverse events (FAERS/openFDA)#

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