CERTUS PVP-1 PREP SWABSTICK- povidone-iodine swab

1. Drug Facts Box Otc Active Ingredient Section
2. Drug Facts Box Otc Purpose Section
3. Drug Facts Box Otc Indications & Usage Section
4. Drug Facts Box Otc Warnings Section
5. Drug Facts Box Otc Do Not Use Section
6. Drug Facts Box Otc Ask Doctor Section
7. Drug Facts Box Otc Stop Use Section
8. Drug Facts Box Otc Keep Out Of Reach Of Children Section
9. Drug Facts Box Otc Dosage & Administration Section
10. Drug Facts Box Otc General Precautions Section
11. Drug Facts Box Otc Inactive Ingredient Section
12. Certus Pvp-1 Prep Swabstick 210012 Pouch

Drug Facts Box Otc Active Ingredient Section  ⮝

Povidone Iodine USP 10%

equivalent to 1% titratable iodine

Drug Facts Box Otc Purpose Section ⮝

Antiseptic

Drug Facts Box Otc Indications & Usage Section ⮝

health-care antiseptic for preparation of the skin prior to surgery

Drug Facts Box Otc Warnings Section ⮝

for external use only

Drug Facts Box Otc Do Not Use Section ⮝

in the eyes

over large areas of the body

on individuals who are allergic or sensitive to iodine

Drug Facts Box Otc Ask Doctor Section ⮝

in case of deep or puncture wounds, animal bites, or serious burns

Drug Facts Box Otc Stop Use Section ⮝

and consult a doctor if redness, irritation, swelling, or pain persists or increases

Drug Facts Box Otc Keep Out Of Reach Of Children Section ⮝

in case of accidental ingestion, seek professional assistance or consult a Poison Control Center immediately

Drug Facts Box Otc Dosage & Administration Section ⮝

for preparation of the skin prior to surgery

remove swab by stick

clean the area

apply product to the operative site prior to surgery

Drug Facts Box Otc General Precautions Section ⮝

store at room temperature 150 - 300 C (590 - 860 F)

Drug Facts Box Otc Inactive Ingredient Section ⮝

disodium phosphate, glycerin, hydroxyethylcellulose, nonoxynol-10, dimethicone, water

Certus Pvp-1 Prep Swabstick 210012 Pouch ⮝

210012.jpg Certus PVP-1 Prep Swabstick pouch

CERTUS PVP-1 PREP SWABSTICK povidone-iodine swab

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75990-4019 Route of Administration TOPICAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POVIDONE-IODINE (UNII: 85H0HZU99M) (POVIDONE-IODINE - UNII:85H0HZU99M) POVIDONE-IODINE 0.1 mL in 1 mL

Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) NONOXYNOL-10 (UNII: K7O76887AP) DIMETHICONE (UNII: 92RU3N3Y1O) HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75990-4019-4 2 mL in 1 POUCH

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 05/01/2011

Labeler - Certus Medical, Inc. (966433653)

Revised: 4/2011 Document Id: fc50a967-7f03-44c3-80e5-ebd469a9c979 34390-5 Set id: d8c726fa-b287-4245-bacf-f9173223ae4d Version: 1 Effective Time: 20110408 Certus Medical, Inc.