Povidone-Iodine Swabstick
JEK PVP-I Swabstick (1's) and (3's)
31d08e09-181b-3a7a-e063-6294a90aa757
HUMAN OTC DRUG LABEL
May 15, 2025
Professional Disposables International, Inc.
DUNS: 800777117
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Povidone Iodine
PRODUCT DETAILS
INGREDIENTS (6)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
S41350 web NDC# 10819-3800-1
S41350 box NDC# 10819-3800-1
S41125 web NDC# 10819-3800-2
S41125 box NDC# 10819-3800-2
INDICATIONS & USAGE SECTION
Uses
- For preparation of the skin prior to surgery
- Helps reduce bacteria that can potentially cause skin infection
OTC - ACTIVE INGREDIENT SECTION
Active ingredient
Povidone-Iodine USP 10% w/w (equivalent to 1.0% titratable iodine)
OTC - PURPOSE SECTION
Purpose
Antiseptic
WARNINGS SECTION
Warnings
For external use only
If swallowed, get medical help or contact a Poison Control Center right away.
Discontinue use if irritation and redness develop. If condition persists for more than 72 hours or gets worse, consult a healthcare provider.
DOSAGE & ADMINISTRATION SECTION
Directions
For preparation of the skin prior to surgery
- clean the treatment area
- remove applicator by end of swabstick
- apply to the operative site prior to surgery
- allow to dry
OTHER SAFETY INFORMATION
Other information
- Store at room temperature
- Avoid excessive heat
INACTIVE INGREDIENT SECTION
Inactive ingredients
Citric Acid, Glycerin, Nonoxynol-10, Purified Water, Sodium Hydroxide
OTC - DO NOT USE SECTION
Do not use
Do not use
- in the eyes, nose or mouth
- on individuals who are allergic or sensitive to iodine
- over large areas of the body
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children
Keep out of reach of children.