DUAL SWAB POVIDONE-IODINE PREP- povidone iodine 
Dynarex Corporation

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

1205 Dynarex Dual Prep and Scrub Swabstick NDC 67777-302-01

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.

Indications and Usage

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;

Ask a Doctor

Ask a doctor before use if you have:

Do Not Use:

Keep Out Of Reach Of Children

Dosage and Administration

Directions

​For pre-operative patient skin preparation:

As a first aid antiseptic:

Tear at notch, remove applicator, use only once.

Inactive Ingredients

Other information

Principal Display panel

Dynarex Dual Swab Prep and Scrub Kit

Item 1207

1207_pouches.jpg

Pouches

DUAL SWAB POVIDONE-IODINE PREP 
povidone iodine kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-414
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67777-414-011 in 1 PACKAGE; Type 1: Convenience Kit of Co-Package04/05/2017
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 125 POUCH 32.5 mL
Part 225 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 AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE7.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
LAURIC DIETHANOLAMIDE (UNII: I29I2VHG38)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67777-302-011.3 mL in 1 POUCH; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C
Part 2 of 2
DUAL SWAB POVIDONE-IODINE PREP 
povidone iodine swab
Product Information
Item Code (Source)NDC:67777-303
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
SODIUM PHOSPHATE, DIBASIC DODECAHYDRATE (UNII: E1W4N241FO)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67777-303-011.3 mL in 1 POUCH; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C11/15/2015
Labeler - Dynarex Corporation (008124539)
Registrant - Dynarex Corporation (008124539)

Revised: 1/2020
Document Id: 9ce84ac9-0a93-1f5f-e053-2a95a90a8456
Set id: 6a23dcb5-67c2-4cfd-9acc-3e3e56f017fb
Version: 11
Effective Time: 20200124
 
Dynarex Corporation