Povidone-Iodine Solution, sterile

Manufacturer: Asia Dynamics Inc., d/b/a ADI Medical
Effective date: 2024-05-02
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-06-01 00:55:19

Label at a glance#

ProductADI Medical PVP-I Pouch, Foil

Active ingredientPOVIDONE-IODINE

Label structure8 sections

Dosage and administration

apply locally as needed

Storage and handling

Avoid excessive heat Store at room temperature

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Povidone-lodine USP 10%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

for antiseptic skin preparation

Warnings

WARNINGS SECTION

For external use only

Avoid pooling beneath patient

do not use

OTC - DO NOT USE SECTION

if allergic to lodine
in the eye

Stop use and ask a 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

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

Ask a doctor before use if injuries are

OTC - ASK DOCTOR SECTION

deep or puncture wounds
serious burns

Directions

DOSAGE & ADMINISTRATION SECTION

apply locally as needed

Other information

SPL UNCLASSIFIED SECTION

1% titratable iodine
for hospital or professional use only

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Nonyl Nonoxynol-10, Glycerin, Purifed Water.

Storage

STORAGE AND HANDLING SECTION

Avoid excessive heat

Store at room temperature

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelNDC 83645-552-11

ADI Medical

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
312564	povidone-iodine 10 % Topical Solution	PSN	2
312564	povidone-iodine 100 MG/ML Topical Solution	SCD	2
312564	povidone-iodine 10 % (titratable iodine 1 % ) Topical Solution	SY	2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
5f30b278-5791-4113-8781-878a9221ef8a	Product name	2	20230125
2a70c781-a755-4d76-b20a-a958acfbdcdc	Product name	2	20190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5	Product name	1	20180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22	Product name	1	20180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5c	Product name	1	20180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896	Product name	1	20170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99	Product name	1	20170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8c	Product name	1	20150421

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
83645-550-11	ADI Medical PVP-I Pouch, Foil	50 in 1 CASE	SOLUTION	50		2
83645-550-11	ADI Medical PVP-I Pouch, Foil	22.5 g in 1 POUCH	SOLUTION	22.5		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
83645-550	ADI MEDICAL PVP-I POUCH, FOIL (POVIDONE-IODINE) SOLUTION [ASIA DYNAMICS INC., D/B/A ADI MEDICAL]	2	Current NDC, 2 package rows	20250216_0e8baf24-0c67-5511-e063-6394a90acaa1.zip

Products#

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

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

ADI Medical PVP-I Pouch, Foil
POVIDONE-IODINE
NONOXYNOL-10
GLYCERIN
WATER
IODINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
83645-550	83645-550-11

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
Name	UNII	Kind
NONOXYNOL-10	K7O76887AP	IACT
GLYCERIN	PDC6A3C0OX	IACT
WATER	059QF0KO0R	IACT
POVIDONE-IODINE	85H0HZU99M	ACTIM

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ADI Medical PVP-I Pouch, Foil	POVIDONE-IODINE	Asia Dynamics Inc., d/b/a ADI Medical	0e8baf24-0c67-5511-e063-6394a90acaa1	2024-05-02	Warnings	Exact identifier ndc (package): 83645-550-11 ndc (product): 83645-550 ndc11 (package): 83645055011 spl id: 177c6100-8045-5eb4-e063-6294a90aa3fa spl set id: 0e8baf24-0c67-5511-e063-6394a90acaa1

Reported adverse events (FAERS/openFDA)#

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