Label: PROFEND NASAL DECOLONIZATION- povidone iodine usp, 10% w/w swab
- NDC Code(s): 10819-3888-2, 10819-3888-3
- Packager: Professional Disposables International, 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.
Updated September 18, 2020
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- Active Ingredient
For external use only
Do not use
- in the eyes or mouth
- on individuals who are allergic or sensitive to iodine
- over large areas of the body
Stop use and ask doctor if irritation and redness develop or if condition persists for more than 72 hours.
Ask a doctor before use if you have
- Deep or puncture wounds
- animal bites
- serious burns
- Keep out of reach of children.
For nasal application:
Step 1: Use tissue to clean inside of both nostrils, including inside tips of nostrils. Discard tissue.
Using total of four swabsticks, perform Steps 2-6 two times for right nostril and two times for left nostril.
Step 2: Hold applicator tube between thumb and forefinger at blue band with tube in vertical position with tip/handle up. With the other hand, place thumb and forefinger at base of handle (“thumb-to-thumb”).
Step 3: Bend and snap open along break line.
Step 4: Bend and snap in opposite direction to disconnect swabstick.
Step 5: Remove swabstick from tube. Discard tube.
Step 6: Insert swabstick comfortably into one nostril. For a total of 15 seconds, rotate swabstick around circumference of nostril and then rotate in the anterior nares for a minimum of 6 complete revolutions with slight pressure, covering all surfaces. Discard swabstick.
Note: Do not blow nose. If solution drips, gently wipe with a tissue.
- Other information
- Inactive Ingredients
- Principal Display Panel
INGREDIENTS AND APPEARANCE
PROFEND NASAL DECOLONIZATION
povidone iodine usp, 10% w/w swab
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10819-3888 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM HYDROXIDE (UNII: 55X04QC32I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10819-3888-3 12 in 1 CARTON 02/16/2018 1 NDC:10819-3888-2 4 in 1 BOX 1 0.75 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 02/16/2018 Labeler - Professional Disposables International, Inc. (800777117) Establishment Name Address ID/FEI Business Operations Professional Disposables International, Inc. 800777117 manufacture(10819-3888)