Dual Swab Povidone-Iodine Prep

Manufacturer
Dynarex Corporation
Effective date
2020-01-24
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
full-release
Hydrated at
2026-05-31 23:03:27

Label at a glance#

ProductDual Swab Povidone-Iodine Prep
Active ingredientPOVIDONE-IODINE
Label structure12 sections

Dosage and administration

Directions ​For pre-operative patient skin preparation: ​Apply to procedure site and allow to dry. discard after single use. If not ready for immediate venipuncture, cover the area with a dry sterile gauze. As a first aid antiseptic: ​clean affected area apply to wound once or twice daily may be covered with a sterile bandage if bandaged let dry first Tear at notch, remove applicator, use only once.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient                                          Purpose

Povidone Iodine Scrub 7.5% w/w                Antiseptic

Povidone Iodine Prep 10% w/w                  Antiseptic

Purpose

OTC - PURPOSE SECTION

Uses

Povidone Iodine Scrub Swabstick - For scrubbing procedure site, prior to antiseptic application.

Povidone Iodine Prep Swabstick - For antiseptic application at procedure site.

INDICATIONS & USAGE SECTION

Indications and Usage

  • For pre-operative patient skin preparation.

Warnings

WARNINGS SECTION

​For External Use Only

Avoid contact with eyes. If contact occurs, flush with water. ​

Stop Use

OTC - STOP USE SECTION

Stop use and ask a healthcare professional if;

  • condition worsens or persists for more than 72 hours
  • if pain, irritation, redness or swelling occurs

Ask a Doctor

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have:

  • deep puncture wounds
  • animal bites
  • serious wounds

OTC - DO NOT USE SECTION

Do Not Use:

  • as a first aid antiseptic for more than 1 week
  • over large areas of the body

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep Out Of Reach Of Children

  • if swallowed, get medical help or contact a Poison Control Center immediately .​

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

Directions

​For pre-operative patient skin preparation:

  • ​Apply to procedure site and allow to dry.
  • discard after single use.
  • If not ready for immediate venipuncture, cover the area with a dry sterile gauze.

As a first aid antiseptic:

  • ​clean affected area
  • apply to wound once or twice daily
  • may be covered with a sterile bandage
  • if bandaged let dry first

Tear at notch, remove applicator, use only once.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

  • Povidone Iodine 7.5% Scrub Solution - Lauramide DEA, water
  • Povidone Iodine 10% Prep Solution - Anhydrous citric acid, disodium hydrogen phosphate, water

Other information

SPL UNCLASSIFIED SECTION

  • Store at room temperature
  • Avoid excessive heat

Principal Display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dynarex Dual Swab Prep and Scrub Kit

Item 1207

1207_pouches.jpg

PouchesPouches

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
797730povidone-iodine 10 % Medicated PadPSN11
1037204povidone-iodine 7.5 % Medicated PadPSN11
797730povidone-iodine 100 MG/ML Medicated PadSCD11
1037204povidone-iodine 75 MG/ML Medicated PadSCD11
797730povidone-iodine 10 % (titratable iodine 1 % ) Medicated PadSY11
797730povidone-iodine 10 % Medicated PadSY11
797730povidone-iodine 10 % Medicated SwabstickSY11
1037204povidone-iodine 7.5 % (titratable iodine 0.75 % ) Topical SwabSY11
1037204povidone-iodine 7.5 % Medicated PadSY11

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
67777-414-012022-01-28C16284748780-1d6a99b39-d422-a426-e053-dadaa90af4c21205 Dynarex Dual Prep and Scrub Swabstick NDC 67777-302-01

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67777-414-01Dual Swab Povidone-Iodine Prep1 in 1 PACKAGEKIT111

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67777-302DUAL SWAB POVIDONE-IODINE PREP (POVIDONE IODINE) KIT [DYNAREX CORPORATION]11Legacy NDC20200125_6a23dcb5-67c2-4cfd-9acc-3e3e56f017fb.zip
67777-303DUAL SWAB POVIDONE-IODINE PREP (POVIDONE IODINE) KIT [DYNAREX CORPORATION]11Legacy NDC20200125_6a23dcb5-67c2-4cfd-9acc-3e3e56f017fb.zip
67777-414DUAL SWAB POVIDONE-IODINE PREP (POVIDONE IODINE) KIT [DYNAREX CORPORATION]11Legacy NDC, 1 package rows20200125_6a23dcb5-67c2-4cfd-9acc-3e3e56f017fb.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99M6
IODINEACTIVE MOIETY9679TC07X46
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSL6
LAURIC DIETHANOLAMIDEINACTIVE INGREDIENTI29I2VHG386
SODIUM PHOSPHATE, DIBASIC ANHYDROUSINACTIVE INGREDIENT22ADO53M6F6
WATERINACTIVE INGREDIENT059QF0KO0R6

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
67777-41467777-414-01
67777-30267777-302-01
67777-30367777-303-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

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 2 · 115 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLFILM, SOLUBLE / BUCCAL2 mgExact identifier — unii candidate
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ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSOLUTION/ DROPS / AURICULAR (OTIC)1 mgExact identifier — unii candidate
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ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLTABLET / BUCCAL30 mgExact identifier — unii candidate
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LAURIC DIETHANOLAMIDELAURIC DIETHANOLAMIDEI29I2VHG38SUSPENSION / TOPICAL0.48 %w/vExact identifier — unii candidate
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ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLELIXIR / ORAL90 mgExact identifier — unii candidate
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SODIUM PHOSPHATE, DIBASIC ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINSERT / INTRAOCULAR0.02 mgExact identifier — unii candidate
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ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLGRANULE, FOR SUSPENSION / ORAL30 mgExact identifier — unii candidate
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ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSYRUP / ORAL268 mgExact identifier — unii candidate
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SODIUM PHOSPHATE, DIBASIC ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION, SOLUTION / INTRAVENOUS2460 mgExact identifier — unii candidate
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ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLPOWDER, FOR SOLUTION / ORAL123 mgExact identifier — unii candidate
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SODIUM PHOSPHATE, DIBASIC ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FCREAM / TOPICAL0.36 %w/wExact identifier — unii candidate
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LAURIC DIETHANOLAMIDELAURIC DIETHANOLAMIDEI29I2VHG38EMULSION / TOPICAL15 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLTABLET / SUBLINGUAL36 mgExact identifier — unii candidate
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ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLPOWDER, FOR SUSPENSION / ORAL570 mgExact identifier — unii candidate
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SODIUM PHOSPHATE, DIBASIC ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FFILM / BUCCAL0.35 mgExact identifier — unii candidate
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ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSPRAY / TOPICAL0.01 %w/wExact identifier — unii candidate
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ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSUSPENSION / RESPIRATORY (INHALATION)1 mgExact identifier — unii candidate
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ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSUSPENSION / ORAL400 mgExact identifier — unii candidate
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SODIUM PHOSPHATE, DIBASIC ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION / SUBCUTANEOUS20 mgExact identifier — unii candidate
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ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSUSPENSION/ DROPS / ORAL15 mgExact identifier — unii candidate
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ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLFILM / SUBLINGUAL11 mgExact identifier — unii candidate
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ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLLIQUID / INTRAVENOUS18 mgExact identifier — unii candidate
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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
9ce84ac9-0a93-1f5f-e053-2a95a90a84566a23dcb5-67c2-4cfd-9acc-3e3e56f017fb2020-01-24WarningsExact identifier
spl id: 9ce84ac9-0a93-1f5f-e053-2a95a90a8456
spl set id: 6a23dcb5-67c2-4cfd-9acc-3e3e56f017fb

Reported adverse events (FAERS/openFDA)#

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