CERTUS PVP-1 PREP SWABSTICK - povidone-iodine swab 
Certus Medical, Inc.

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.

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Certus PVP-1 Prep Swabstick 210012 Drug Facts and Label

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  image of pouch label

CERTUS PVP-1 PREP SWABSTICK 
povidone-iodine swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75990-4019
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (POVIDONE-IODINE - UNII:85H0HZU99M) POVIDONE-IODINE0.1 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75990-4019-42 mL in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E05/01/2011
Labeler - Certus Medical, Inc. (966433653)

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