DUAL SWAB POVIDONE-IODINE PREP- povidone iodine kit

Dual Swab Povidone-Iodine Prep by

Drug Labeling and Warnings

Dual Swab Povidone-Iodine Prep by is a Otc medication manufactured, distributed, or labeled by Dynarex Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient                                          Purpose

Povidone Iodine Scrub 7.5% w/w                Antiseptic

Povidone Iodine Prep 10% w/w                  Antiseptic

Purpose

Uses

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

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

SPL UNCLASSIFIED SECTION

INDICATIONS & USAGE

Indications and Usage

• For pre-operative patient skin preparation.

Warnings

​For External Use Only

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

Stop Use

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

Ask a doctor before use if you have:

• deep puncture wounds
• animal bites
• serious wounds

DO NOT USE

Do Not Use:

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

KEEP OUT OF REACH OF CHILDREN

Keep Out Of Reach Of Children

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

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.

Inactive Ingredients

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

Other information

• Store at room temperature
• Avoid excessive heat

Principal Display panel

Dynarex Dual Swab Prep and Scrub Kit

Item 1207

1207_pouches.jpg

INGREDIENTS AND APPEARANCE

DUAL SWAB POVIDONE-IODINE PREP 
povidone iodine kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67777-414

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67777-414-01	1 in 1 PACKAGE; Type 1: Convenience Kit of Co-Package	04/05/2017

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	25 POUCH	32.5 mL
Part 2	25 POUCH	32.5 mL

Part 1 of 2

DUAL SWAB POVIDONE-IODINE PREP 
povidone iodine swab

Product Information
Item Code (Source)	NDC: 67777-302
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	7.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
LAURIC DIETHANOLAMIDE (UNII: I29I2VHG38)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67777-302-01	1.3 mL in 1 POUCH; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C

Part 2 of 2

DUAL SWAB POVIDONE-IODINE PREP 
povidone iodine swab

Product Information
Item Code (Source)	NDC: 67777-303
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SODIUM PHOSPHATE, DIBASIC DODECAHYDRATE (UNII: E1W4N241FO)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67777-303-01	1.3 mL in 1 POUCH; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	11/15/2015

Labeler - Dynarex Corporation (008124539)

Registrant - Dynarex Corporation (008124539)