GRX DYNE - 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 Solution

Drug Facts

Active Ingredient:                      Purpose

Povidone Iodine USP, 10% w/v  Antiseptic

(equivalent to 1% titratable Iodine)

Uses

First aid antiseptic to help the risk of infection in

minor cuts, scrapes or burns

Directions

Clean the affected area

Apply a small amount of this product to the area 1-3 times daily

May be covered with a sterile bandaged

If bandaged, let dry first

Apply a small amount of this product to the affected area 1-3 times daily

Warnings

FOR EXTERNAL USE ONLY

DO NOT

Use in the eyes

Use on individuals who are allergic of sensitive to iodine

Apply over large areas of the body

Discontinue use and ask a doctor

If condition persist or gets worse

For use longer than 1 week

Ask a doctor in case of

Deep or punctured wounds

Animal bites

Serious burns

Inactive Ingredient

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

Store at room temperature: 15'-30'C (59'-86'F)

keep out of reach of children. If swallowed get medical help

or contact a Poison Control Center right away.

Label of BottleEnter section text here

GRX DYNE 
povidone iodine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54162-269
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (POVIDONE-IODINE - UNII:85H0HZU99M) POVIDONE-IODINE10 mL  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:54162-269-16472 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/16/2012
Labeler - Geritrex Corp. (112796248)

Revised: 5/2012
Document Id: f20e255c-14cc-4eab-a72b-90000cc0a45b
Set id: 40091a7b-f107-44bf-9bf0-f58a8cafda83
Version: 1
Effective Time: 20120516
 
Geritrex Corp.