Active Ingredient
10% Povidone Iodine Solution USP (1% available iodine)
Povidone Iodine
FDA Label NDC 68183-116
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 (NDC 68183-116). 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, directions, warnings, ask a doctor before use if you have, stop use, keep out of reach of children, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical Antiseptic
Directions
Reverse cardboard sleeve then crush at dot between thumb and forefinger. Allow solution to saturate tip and apply soltion to injury.
Reverse cardboard sleeve then crush at dot between thumb and forefinger. Allow solution to saturate tip and apply solution to injury.
Warnings
- For External Use Only
Ask A Doctor Before Use If You Have
Deep or puncture wounds
Serious Burns
Stop Use
redness, irritation, swelling or pain persists or increases
infection occurs
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away
Other Information
Store at room temperature away from light keep from freezing or excessive heat
Inactive Ingredient
Citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water
Package Label.Principal Display Panel
Povidone Iodine Swab (U116apovswab)
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