Label: GRX DYNE SCRUB - povidone-iodine solution
- NDC Code(s): 54162-268-04
- 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.
Updated July 3, 2012
If you are a consumer or patient please visit this version.
- Active Ingredient
Active Ingredient: Purpose
Povidone-Iodine, 7.5% Antiseptic
(Equal to 0.75% available Iodine) Close
Disinfectant hand wash and skin cleanser.
Significantly reduces bacteria on the skin.Close
Wet skin and apply a sufficient amount for lather to
cover all surfaces.
Wash vigorously for at least 15 seconds.
Rinse and dry thoroughly.Close
- DOSAGE & ADMINISTRATION
Wash vigorously for at least 15 seconds. Close
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 Close
- STORAGE AND HANDLING
Store at 25'C (77'F); excursions permitted between
- KEEP OUT OF REACH OF CHILDREN
If swallowed get medical help or contact a Poison Control Center right away.Close
- PRINCIPAL DISPLAY PANEL
Enter section text hereClose
- INGREDIENTS AND APPEARANCE
GRX DYNE SCRUB
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54162-268 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POVIDONE-IODINE (UNII: 85H0HZU99M) (POVIDONE-IODINE - UNII:85H0HZU99M) POVIDONE-IODINE 7500 mg 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:54162-268-04 118 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 07/03/2012 Labeler - Geritrex Corp. (112796248)