Label: POVIOFIX ANTISEPTIC- povidone-iodine solution
- NDC Code(s): 69249-000-00
- Packager: NATUREL MEDIKAL ILAC SANAYI VE TICARET LIMITED SIRKETI
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 21, 2023
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
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Uses
- Surgical hand scrub: significantly reduces the number of micro-organisms on the hands and forearms prior to surgery or patient care.
- Patient preoperative skin preparation: for preparation of the skin prior to surgery. Helps reduce bacteria that potentially can cause skin infection.
- First aid to help decrease the risk of infection in minor cuts, scrapes, and burns.
- Warnings
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Directions
Surgical hand scrub (for use without water):
Patient preoperative skin preparation:
First-aid antiseptic:
- clean under nails with a nail pick
- nails should be maintained with a 1 millimeter free edge
- place a ‘palmful’ (5 grams) of product in one hand spread on both hands, paying particular attention to the nails, cuticles, and interdigital spaces, and rub into the skin until dry (approximately 1 to 2 minutes)
- place a smaller amount (2.5 grams) into one hand, spread over both hands to wrist, and rub into the skin until dry (approximately 30 seconds)
- clean the area
- apply product to the operative site prior to surgery
- clean the affected area. May be covered with a sterile bandage.
- If bandaged, let dry first.
- If used as a wet compress bandage lightly. Keep bandage wet with solution.
- Other information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
- Product Label
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INGREDIENTS AND APPEARANCE
POVIOFIX ANTISEPTIC
povidone-iodine solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69249-000 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE 100 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) GLYCERIN (UNII: PDC6A3C0OX) POLYSORBATE 20 (UNII: 7T1F30V5YH) SODIUM CITRATE (UNII: 1Q73Q2JULR) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69249-000-00 1 in 1 CARTON 09/25/2014 1 1000 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug 505G(a)(3) 09/25/2014 Labeler - NATUREL MEDIKAL ILAC SANAYI VE TICARET LIMITED SIRKETI (355602127)