Label: CERTUS PVP-1 PREP SWABSTICK- povidone-iodine swab
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Contains inactivated NDC Code(s)
NDC Code(s): 75990-4019-4 - Packager: Certus Medical, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated April 8, 2011
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- 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
- 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
- Drug Facts Box OTC Dosage & Administration Section
- Drug Facts Box OTC General Precautions Section
- Drug Facts Box OTC Inactive Ingredient Section
- Certus PVP-1 Prep Swabstick 210012 pouch
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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)