CERTUS PVP-1 PREP SWABSTICK- povidone-iodine swab

Drug Labeling and Warnings

Drug Details [pdf]

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 

INGREDIENTS AND APPEARANCE

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)