Otc - Active Ingredient
Povidone-Iodine, 10% w/w
Povidone-iodine Prep Pads Medium Cloth
FDA Label NDC 51662-1667
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Hf Acquisition Co. Llc, Dba Healthfirst for the product Povidone-iodine Prep Pads Medium (NDC 51662-1667). 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 otc - active ingredient, otc - purpose, uses, warnings, otc - keep out of reach of children, directions, other safety information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Antiseptic
Uses
First aid antiseptic to help prevent infection in minor cuts, scrapes and burns
Warnings
For external use only.
Do not use
in the eyes
longer than 1 week unless directed by a physician
on individuals who are allergic or sensitive to iodine
or apply over large areas of the body
Stop use and ask a doctor if
irritation and redness develop
condition persists for more than 72 hours
in case of deep or puncture wounds, animal bites or serious burns
Keep out of reach of children.
If swallowed, get medical assistance or immediately contact a Poison Control Center.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
If swallowed, get medical assistance or immediately contact a Poison Control Center.
Directions
clean the affected area
apply a small amount of this product on the area 1 to 3 times daily.
may be covered with a sterile bandage
if bandaged, let dry first
Other Safety Information
do not flush
protect from freezing, avoid excessive heat
Inactive Ingredient
citric acid, disodium phosphate, water
Otc - Stop Use
Stop use and ask a doctor if
irritation and redness develop
condition persists for more than 72 hours
in case of deep or puncture wounds, animal bites or serious burns
Otc - Ask Doctor
Stop use and ask a doctor if
irritation and redness develop
condition persists for more than 72 hours
in case of deep or puncture wounds, animal bites or serious burns
Dosage & Administration
First aid antiseptic to help prevent infection in minor cuts, scrapes and burns
clean the affected area
apply a small amount of this product on the area 1 to 3 times daily.
may be covered with a sterile bandage
if bandaged, let dry first
Indications & Usage
clean the affected area
apply a small amount of this product on the area 1 to 3 times daily.
may be covered with a sterile bandage
if bandaged, let dry first
Package Label.Principal Display Panel
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