NDC | 54162-269-16 |
Set ID | 40091a7b-f107-44bf-9bf0-f58a8cafda83 |
Category | HUMAN OTC DRUG LABEL |
Packager | Geritrex Corp. |
Generic Name | |
Product Class | Antiseptic |
Product Number | |
Application Number | PART333A |
- Drug Facts
Active Ingredient: Purpose
Povidone Iodine USP, 10% w/v Antiseptic
(equivalent to 1% titratable Iodine)
Close - Uses
- 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
Close - DOSAGE & ADMINISTRATION
Apply a small amount of this product to the affected area 1-3 times daily Close
- 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
Close - Inactive Ingredient
- STORAGE AND HANDLING
- KEEP OUT OF REACH OF CHILDREN
keep out of reach of children. If swallowed get medical help
or contact a Poison Control Center right away.
Close - PRINCIPAL DISPLAY PANEL
- 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:54162-269-16 472 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)