Active Ingredient
Povidone Iodine 10%
Povidone Iodine Prep Pads
FDA Label NDC 68183-119
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Custom Kits Company Inc for the product Povidone Iodine Prep Pads (NDC 68183-119). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, do not use, ask doctor before use if you have, stop use and ask doctor if, keep out of the reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antiseptic
Uses
Antiseptic cleanser to help prevent skin infection in minor cuts, scrapes and burns.
For preparation of the skin prior to surgery
Helps reduct bacteria that can potentially cause skin infection
Warnings
For External Use Only
Do Not Use
In the eyes
As a first aid antiseptic for more than 1 week
Over large areas of the body
Ask Doctor Before Use If You Have
Deep or puncuture wounds
Animal bites
Serious wounds
Stop Use And Ask Doctor If
Condition worsens or persists for more than 72 hours
Irritation and rednes develops
Keep Out Of The Reach Of Children
If swallowed, get medical help or contact a Poson Control Center immediately
Directions
Tear at notch
Remove applicator
Use only once
As a first aid antiseptic - Clean affected area
apply 1 to 3 times daily
May be covered with a sterile bandage
If bandaged let dry first
Other Safety Information
Store at room temperature
Avoid excessive heat
Inactive Ingredient
nonoxynol-9, water
Package Label.Principal Display Panel
Pvp.jpg (Pvp)
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