Label: GRX DYNE SCRUB- povidone-iodine solution
- 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
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- Active Ingredient
- DOSAGE & ADMINISTRATION
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
- STORAGE AND HANDLING
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
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)