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 Type HUMAN OTC DRUG Item Code (Source) NDC:54162-269
Route of Administration TOPICAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (POVIDONE-IODINE - UNII:85H0HZU99M) POVIDONE-IODINE 10 mL  in 100 mL
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCERIN (UNII: PDC6A3C0OX)  
NONOXYNOL-10 (UNII: K7O76887AP)  
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:54162-269-16 472 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 05/16/2012
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.