Label: GRX DYNE- povidone iodine solution
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Contains inactivated NDC Code(s)
NDC Code(s): 54162-269-04 - Packager: Geritrex Corp.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated May 21, 2012
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- Official Label (Printer Friendly)
- Drug Facts
- Uses
- Directions
- DOSAGE & ADMINISTRATION
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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
- STORAGE AND HANDLING
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
GRX DYNE
povidone iodine solutionProduct 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:54162-269-04 118 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 05/21/2012 Labeler - Geritrex Corp. (112796248)