GRX DYNE SCRUB - povidone-iodine solution 
Geritrex Corp.

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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GRx Dyne Scrub

Active Ingredient

Active Ingredient:                      Purpose

Povidone-Iodine, 7.5%              Antiseptic

(Equal to 0.75% available Iodine)

uses

Disinfectant hand wash and skin cleanser.

Significantly reduces bacteria on the skin.

Directions

Wet skin and apply a sufficient amount for lather to

cover all surfaces.

Wash vigorously for at least 15 seconds.

Rinse and dry thoroughly.

Wash vigorously for at least 15 seconds.

Warnings

For External Use Only

Do not use this product:

If you are sensitive to iodine or other products ingredients.

In the eyes.

Over large areas of the body.

Longer than 1 week unless directed by a doctor.

Ask a doctor before use if you have

Deep puncture wounds: serious burns: or animal bites.

Stop using this product and ask a doctor if;

Redness, irritation, swelling, or pain continues or increases, or infection occurs.


Inactive Ingredient

Citric acid, glycerin, Nonoxynol 10, purified water, sodium hydroxide

Store at 25'C (77'F); excursions permitted between

15'-30'C (59'-86'F)

If swallowed get medical help or contact a Poison Control Center right away.

Label of BottleEnter section text here

GRX DYNE SCRUB 
povidone-iodine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54162-268
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (POVIDONE-IODINE - UNII:85H0HZU99M) POVIDONE-IODINE7500 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCERIN (UNII: PDC6A3C0OX)  
NONOXYNOL-10 (UNII: K7O76887AP)  
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54162-268-04118 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/03/2012
Labeler - Geritrex Corp. (112796248)

Revised: 7/2012
Document Id: c5de7b12-7ebb-4030-87fc-7f0df2442ab0
Set id: 4779974e-c149-489d-9cce-a0e9e0e921c9
Version: 1
Effective Time: 20120703
 
Geritrex Corp.