A3129-17 PORTEX SINGLE SHOT EPIDURAL

Manufacturer: Smiths Medical ASD, Inc. | Aplicare, Inc.
Effective date: 2016-10-13
Label type: MEDICAL DEVICE
Version: 3
Source: legacy-cache
Hydrated at: 2026-08-02 01:22:27

Label at a glance#

ProductA3129-17 PORTEX SINGLE SHOT EPIDURAL

Active ingredientPOVIDONE-IODINE

Label structure11 sections

Contacts and useful links#

PhoneLabel contact1 800 760-3236

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Povidone-iodine

OTC - PURPOSE SECTION

Antiseptic

Antiseptic skin preparation

WARNINGS SECTION

Do not use

-if allergic to iodine

-in the eyes

For external use only

Ask a doctor before use if injuries are

-deep or puncture wounds

-serious burns

OTC - STOP USE SECTION

Stop use and ask a doctor if

-redness, irritation, swelling or pain persists or increases

-infection occurs

Avoid pooling beneath patient

Avoid excessive heat. Store at room temperature.

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.

INSTRUCTIONS FOR USE SECTION

Apply locally as needed.

OTHER SAFETY INFORMATION

1% titratable iodine
latex free
for hospital or professional use only

INACTIVE INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

1 800 760-3236 (Mon to Fri 8:30 AM-5:00 PM EST)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

APLICARE

POVIDONE-IODINE SOLUTION

ANTISEPTIC

STERILE Solution

Povidone Iodine Solution

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Label Display Panel

A3129-17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52380-0001-1	ML - Milliliter	52380-0001	edd25a2a-aabd-433e-b5a8-ef9471c1b244	1	2012-07-24
52380-0001-3	ML - Milliliter	52380-0001	9f05eb45-3f8e-4fd9-814a-476eb917bf5c	1	2021-11-09
52380-0001-5	EA - Each	52380-0001	9755da7f-19a8-4706-8c70-17752ffe4175	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
POVIDONE-IODINE	ACTIVE INGREDIENT	85H0HZU99M	1
IODINE	ACTIVE MOIETY	9679TC07X4	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	1
NONOXYNOL-9	INACTIVE INGREDIENT	48Q180SH9T	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	1
SODIUM PHOSPHATE, DIBASIC	INACTIVE INGREDIENT	GR686LBA74	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

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

A3129-17 PORTEX SINGLE SHOT EPIDURAL
Aplicare Povidone-Iodine
Povidone-Iodine
IODINE
CITRIC ACID MONOHYDRATE
SODIUM PHOSPHATE, DIBASIC
SODIUM HYDROXIDE
NONOXYNOL-9
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
51688-9616	51688-9616-2
52380-0001	52380-0001-3

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
Name	UNII	Kind
POVIDONE-IODINE	85H0HZU99M	ACTIM
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
SODIUM PHOSPHATE, DIBASIC	GR686LBA74	IACT
SODIUM HYDROXIDE	55X04QC32I	IACT
NONOXYNOL-9	48Q180SH9T	IACT
WATER	059QF0KO0R	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 5 · 278 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRACARDIAC	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SOLUTION / SUBMUCOSAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC	SODIUM PHOSPHATE, DIBASIC	GR686LBA74	FILM, SOLUBLE / ORAL		9 mg	Exact identifier — unii candidate 14 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, COATED / ORAL	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / PERIODONTAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	POWDER, FOR SUSPENSION / ORAL		840 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SYRUP / ORAL	71 mg/5ml		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	CREAM, AUGMENTED / TOPICAL		6 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / EPIDURAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / DENTAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRA-ARTICULAR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TROCHE / ORAL	12 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SYSTEM / TOPICAL	0.2 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	CONCENTRATE / ORAL	10 mg/5ml		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	CAPSULE, DELAYED RELEASE / ORAL	0.25 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / SOFT TISSUE	ADJ PH		Exact identifier — unii candidate 88 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	GEL / TRANSDERMAL		472 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC	SODIUM PHOSPHATE, DIBASIC	GR686LBA74	INJECTION / INTRADERMAL	0.2 %w/v		Exact identifier — unii candidate 14 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SOLUTION / INTRAMUSCULAR		78 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	POWDER, FOR SUSPENSION / ENDOTRACHEAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SOLUTION / INTRA-ARTERIAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INTRATHECAL	ADJ PH		Exact identifier — unii candidate 88 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SUSPENSION/ DROPS / OPHTHALMIC	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	TABLET, EXTENDED RELEASE / ORAL		13 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SOLUTION / EPIDURAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / AURICULAR (OTIC)	0.2 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SUSPENSION, EXTENDED RELEASE / INTRASYNOVIAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	LOTION / TOPICAL		21 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INTRAPLEURAL	ADJ PH		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	POWDER, FOR SOLUTION / TOPICAL	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	POWDER / RESPIRATORY (INHALATION)	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / TOPICAL		17 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / INTRATHECAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	JELLY / TOPICAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	NA		Exact identifier — unii candidate 174 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	AEROSOL, FOAM / RECTAL		7 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, FOR SOLUTION / PARENTERAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	FILM / SUBLINGUAL		10 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRACAVITARY	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SUSPENSION, EXTENDED RELEASE / ORAL	140.8 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	LOTION / TOPICAL	0.85 %w/w		Exact identifier — unii candidate 88 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	POWDER / INTRAVENOUS	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	TABLET / ORAL		10 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SOLUTION/ DROPS / AURICULAR (OTIC)	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	LIQUID / INTRAMUSCULAR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SUSPENSION / INTRA-ARTICULAR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SPONGE / TOPICAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SOLUTION / INTRAVASCULAR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / SUBCUTANEOUS		28 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SUSPENSION / OPHTHALMIC	ADJ PH		Exact identifier — unii candidate 88 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	GEL / TOPICAL		70 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION, CONCENTRATE / INTRAVENOUS	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRALESIONAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / EPIDURAL	0.02 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SWAB / TOPICAL	0.01 %w/w		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	EMULSION / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 174 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, FILM COATED / ORAL		42 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC	SODIUM PHOSPHATE, DIBASIC	GR686LBA74	INJECTION / INTRAMUSCULAR	40 mg		Exact identifier — unii candidate 14 equally ranked IID candidates

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 9 · 165 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Henry Schein Povidone-Iodine Prep Pad	POVIDONE-IODINE	Henry Schein, Inc.	313416b8-60b2-4a77-9b56-5c507aae9072	2026-09-08	Warnings	Name fallback generic name: POVIDONE-IODINE
Aplicare Povidone-Iodine	POVIDONE-IODINE	Aplicare Products, LLC	7302a2f8-a600-4200-bc4e-309e4c190fe5	2026-09-02	Warnings	Name fallback generic name: POVIDONE-IODINE
Aplicare Povidone-iodine Scrub	POVIDONE-IODINE	Aplicare Products, LLC	b8a23a29-2541-4987-a534-17a6369a6c8d	2026-09-02	Warnings	Name fallback generic name: POVIDONE-IODINE
Povidone-Iodine Topical Antiseptic	POVIDONE-IODINE	Medline Industries, LP	c9036a83-22f5-4a09-b01c-7093d4192c19	2026-08-28	Warnings	Name fallback generic name: POVIDONE-IODINE
Povidone-Iodine	POVIDONE-IODINE	Major Pharmaceuticals	59041ca3-a195-5a20-e063-6394a90a2ac9	2026-08-14	Warnings	Name fallback generic name: POVIDONE-IODINE
Lights Povidone Iodine Swabsticks	POVIDONE-IODINE	Lights Medical Manufacture Co., Ltd.	664bbf9f-650a-45fd-b9b8-d93f0ba63190	2026-07-22	Warnings	Name fallback generic name: POVIDONE-IODINE
McKesson PVP Prep Solution	POVIDONE-IODINE	McKesson Medical-Surgical	33fa233c-b43c-42d8-af37-a58f098a0d51	2026-07-21	Warnings	Name fallback generic name: POVIDONE-IODINE
Aplicare Povidone-iodine Scrub	POVIDONE-IODINE	Aplicare Products, LLC	ff19ea2f-d6a0-442f-8f23-d559fc13c549	2026-07-14	Warnings	Name fallback generic name: POVIDONE-IODINE
Medline	POVIDONE-IODINE	Medline Industries, LP	1d731a44-f16e-c249-e063-6294a90a39b8	2026-07-08	Warnings	Name fallback generic name: POVIDONE-IODINE
Povidone-Iodine	POVIDONE-IODINE	CARDINAL HEALTH 110, LLC. DBA LEADER	4f0d8da5-a75b-acc7-e063-6394a90ae839	2026-07-08	Warnings	Name fallback generic name: POVIDONE-IODINE
PVP-I Prep Pad	POVIDONE-IODINE	Professional Disposables International, Inc.	57b02fbb-a9a6-0b8c-e063-6394a90a44f3	2026-06-22	Warnings	Name fallback generic name: POVIDONE-IODINE
Povidone-Iodine Scrub Solution	POVIDONE-IODINE	Changzhou Maokang Medical Products Co., Ltd	efa7f9f6-ae02-4104-bb9e-16e1ffd2be7a	2026-06-17	Warnings	Name fallback generic name: POVIDONE-IODINE
Povidone-Iodine	POVIDONE-IODINE	H E B	4a7a627c-505d-992b-e063-6394a90a54ca	2026-06-04	Warnings, Adverse reactions	Name fallback generic name: POVIDONE-IODINE
Povidone Iodine	POVIDONE-IODINE	Amerisource Bergen	f69a5cec-04f2-4028-94c6-1f129d2de5a9	2026-06-04	Warnings	Name fallback generic name: POVIDONE-IODINE
Maokang Povidone-Iodine Paint Solution Antiseptic	POVIDONE-IODINE	Changzhou Maokang Medical Products Co., Ltd	48f81109-3791-46ef-8992-d53b677a51b6	2026-06-02	Warnings	Name fallback generic name: POVIDONE-IODINE
Swab Applicator Brushe7.5% w/w Povidone-Iodine (PVP)	POVIDONE-IODINE	XINXIANG XINDA TECHNOLOGY CO.,LTD	51c29301-978a-0d46-e063-6394a90ab9e4	2026-05-14	Warnings	Name fallback generic name: POVIDONE-IODINE
Lightning X Iodine Prep Pads	POVIDONE-IODINE	Changzhou Maokang Medical Products Co., Ltd.	5136a99b-ef40-937e-e063-6394a90a0a95	2026-05-07	Warnings	Name fallback generic name: POVIDONE-IODINE
First Aid Antiseptic	POVIDONE-IODINE	Retail Business Services, LLC	ad4e49b6-5784-4880-950b-6e6175fc312b	2026-04-30	Warnings, Adverse reactions	Name fallback generic name: POVIDONE-IODINE
3M Skin and Nasal Antiseptic	POVIDONE-IODINE	Solventum US LLC	1a94494d-7dd3-4f32-bc42-81c199fe233e	2026-04-22	Warnings	Name fallback generic name: POVIDONE-IODINE
First Aid Antiseptic	POVIDONE-IODINE	Amazon.com Services LLC	3e2b255c-e3b7-468c-9ac1-b63279c5ac7f	2026-03-20	Warnings, Adverse reactions	Name fallback generic name: POVIDONE-IODINE

Reported adverse events (FAERS/openFDA)#

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