FDA.reportPublic FDA data

Povidone-Iodine Pad

Manufacturer
Shandong Haiyan Medical Manufacture Co., Ltd.
Effective date
2022-03-19
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:35:03

Label at a glance#

ProductPovidone-Iodine Pad
Active ingredientPOVIDONE-IODINE
Label structure6 sections

Dosage and administration

Apply locally as needed. Other Information Store at room temperature: 59°- 86°F(15 - 30℃)

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Povidone Iodine 10% w/w (equivalent to iodine 1%)

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

Antiseptic for preparation of the skin.

Warnings

WARNINGS SECTION

For external use only.
Discontinue use if irritation and redness develop.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of Children.

Directions

DOSAGE & ADMINISTRATION SECTION


Apply locally as needed.
Other Information

Store at room temperature: 59°- 86°F(15 - 30℃)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Purified Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

haiyan002
haiyan002

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42339-003-01Povidone-Iodine Pad100 in 1 BOXSWAB1004
42339-003-01Povidone-Iodine Pad10 in 1 CONTAINERSWAB104
42339-003-02Povidone-Iodine Pad100 in 1 CONTAINERSWAB1004
42339-003-02Povidone-Iodine Pad100 in 1 BOXSWAB1004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42339-003POVIDONE-IODINE PAD (POVIDONE-IODINE) SWAB [SHANDONG HAIYAN MEDICAL MANUFACTURE CO., LTD.]4Current NDC, Legacy NDC, 4 package rows20241108_c9187a07-92d5-15ac-e053-2995a90af4cb.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42339-00342339-003-01, 42339-003-02

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
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM PHOSPHATESE337SVY37IACT
WATER059QF0KO0RIACT
POVIDONE-IODINE85H0HZU99MACTIM

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 PadPOVIDONE-IODINEShandong Haiyan Medical Manufacture Co., Ltd.c9187a07-92d5-15ac-e053-2995a90af4cb2022-03-19WarningsExact identifier
ndc (package): 42339-003-01
ndc (package): 42339-003-02
ndc (product): 42339-003
ndc11 (package): 42339000302
ndc11 (package): 42339000301
spl id: da8c3af9-5d83-1c41-e053-2a95a90acc13
spl set id: c9187a07-92d5-15ac-e053-2995a90af4cb

Reported adverse events (FAERS/openFDA)#

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