FDA.reportPublic FDA data

Povidone Iodine Swabsticks

Manufacturer
Shaoxing Fuqing Health Products Co., Ltd.
Effective date
2018-03-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:55:08

Label at a glance#

ProductPovidone Iodine Swabsticks
Active ingredientPOVIDONE-IODINE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: Povidone-Iodine USP (10%)

OTC - PURPOSE SECTION

Purpose: Antiseptic

INDICATIONS & USAGE SECTION

Use: Antiseptic skin preparation

WARNINGS SECTION

Warnings:

Do not use

  • if allergic to iodine
  • in the eyes

For external use only

Avoid "pooling" beneath patients.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of accidental ingestion, seek professional assistance or consult a poison control center immediately

OTC - ASK DOCTOR SECTION

Ask a doctor before use if injuries are

  • deep or puncture wounds
  • serious burns

Stop use and ask a doctor if

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

DOSAGE & ADMINISTRATION SECTION

Apply locally as need

OTHER SAFETY INFORMATION

Other information

  • For hospital or professional use only

INACTIVE INGREDIENT SECTION

Inactive Ingredient

Citric Acid, Glycerin, Nonoxyol-10, Sodium Hydroxide, Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
65028-008-012020-01-31C16284748780-19d75b9cf-fa0a-f424-e053-dadaa90a57ce6cd4a973-b29f-4f34-87ef-3da5fc2cd005
65028-008-022020-01-31C16284748780-19d75b9cf-fa0a-f424-e053-dadaa90a57ce6cd4a973-b29f-4f34-87ef-3da5fc2cd005

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65028-008-01Povidone Iodine Swabsticks3 in 1 POUCHSWAB31
65028-008-02Povidone Iodine Swabsticks1 in 1 POUCHSWAB11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65028-008POVIDONE IODINE SWABSTICKS (POVIDONE-IODINE) SWAB [SHAOXING FUQING HEALTH PRODUCTS CO., LTD.]1Legacy NDC, 2 package rows20180402_6cd4a973-b29f-4f34-87ef-3da5fc2cd005.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65028-00865028-008-01, 65028-008-02

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
WATER059QF0KO0RIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM HYDROXIDE55X04QC32IIACT
GLYCERINPDC6A3C0OXIACT
NONOXYNOL-10K7O76887APIACT

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
98cd7af2-92bf-4e0f-adb2-b8c0083d0df76cd4a973-b29f-4f34-87ef-3da5fc2cd0052018-03-30WarningsExact identifier
spl id: 98cd7af2-92bf-4e0f-adb2-b8c0083d0df7
spl set id: 6cd4a973-b29f-4f34-87ef-3da5fc2cd005

Reported adverse events (FAERS/openFDA)#

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