First Aid Only Povidone-iodine Antiseptic Patch
FDA Label NDC 0924-8113
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Acme United Corporation for the product First Aid Only Povidone-iodine Antiseptic (NDC 0924-8113). 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 drug facts, active ingredient, purpose, use, warnings, do not use, ask a doctor before use if you have, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Povidone-lodine 10%
Purpose
Antiseptic
Use
First aid antiseptic to help prevent skin infection
Warnings
For external use only
Do Not Use
▪ in eyes ▪ over large areas of the body ▪ if allergic to any of the ingredients
▪ longer than 1 week unless directed by a doctor
.
Ask A Doctor Before Use If You Have
▪ deep or puncture wounds ▪ animal bites ▪ serious burns
Stop Use And Ask A Doctor If
▪ conditions worsen or clear up and then recur
▪ the condition persists for more than 7 days
Keep Out Of Reach Of Children.
If swallowed get medical help or contact a Poison Control Center right away.
Driections
Open packet and wipe affected area. Apply 1 to 3 times daily. May be covered with a sterile bandage. If bandaged, let dry first.
Other Information
Store at room temperature.
Inactive Ingredients:
alkyl glucoside, citric acid, glycerin, hydroxyethyl cellulose, nonoxynol-10, potassium iodide,
purified water, sodium hydroxide
Package Label.Principal Display Panel
Pouch label
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