DUAL SWAB SCRUB SWABSTICK- povidone iodine swab 
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.

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Dual Swab Povidone Iodine Prep Swabstick

Active Ingredient

Active ingredient                Purpose

Povidone iodine 10%        Antiseptic

Purpose

For antiseptic application at  procedure site.

Indications and usage

For pre-operative patient skin preparation.

Warnings

​For External Use Only

Avoid contact with the 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

Do not use:

Keep out of reach of children

Keep out of reach of children:

Dosage and administration

Directions

For preoperative patient skin preparation:

As a first aid antiseptic:

Tear at notch, remove applicator, use only once.

Inactive ingredients

Anhydrous citric acid, disodium hydrogen phosphate, Water

Other information

Principal Display Panel

Dynarex Dual Swab Povidone Iodine Prep Swabstick

Item #: 1210

1210 Prep.jpg

Prep Swabstick

DUAL SWAB SCRUB SWABSTICK 
povidone iodine swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-303
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
SODIUM PHOSPHATE, DIBASIC ANHYDROUS (UNII: 22ADO53M6F)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67777-303-010.3 g in 1 POUCH; Type 0: Not a Combination Product
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)
Establishment
NameAddressID/FEIBusiness Operations
Sion Biotext Medical Ltd532775194manufacture(67777-303)

Revised: 11/2015
Document Id: e790de87-37b9-4859-bb5a-265767a309ea
Set id: 8092e6e8-467a-4260-977f-96c509c64832
Version: 1
Effective Time: 20151104
 
Dynarex Corporation