NDC | 75990-4019-4 |
Set ID | d8c726fa-b287-4245-bacf-f9173223ae4d |
Category | HUMAN OTC DRUG LABEL |
Packager | Certus Medical, Inc. |
Generic Name | |
Product Class | Antiseptic |
Product Number | |
Application Number | PART333E |
- Drug Facts Box OTC Active Ingredient Section
- Drug Facts Box OTC Purpose Section
- Drug Facts Box OTC Indications & Usage Section
- Drug Facts Box OTC Warnings Section
- 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
Close - Drug Facts Box OTC Ask Doctor Section
- Drug Facts Box OTC Stop Use Section
- 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
Close - 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
- Drug Facts Box OTC Inactive Ingredient Section
- Certus PVP-1 Prep Swabstick 210012 pouch
- INGREDIENTS AND APPEARANCE
CERTUS PVP-1 PREP SWABSTICK
povidone-iodine swabProduct 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)