Active Ingredient
Povidone-iodine USP 10%
Medline Swab
FDA Label NDC 53329-120
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Medline Industries, Lp for the product Medline (NDC 53329-120). 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 a doctor before use if injuries are, keep out of reach of children., avoid excessive heat., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antiseptic
Uses
- antiseptic skin preparation
- help reduce bacteria that potentially can cause skin infections
Warnings
For external use only.
Do Not Use
- if allergic to iodine
- in the eyes
- on children less than 3 years old
Ask A Doctor Before Use If Injuries Are
- deep or puncture wounds
- serious burns
Keep Out Of Reach Of Children.
In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.
Avoid Excessive Heat.
Protect from freezing, avoid excessive heat.
Temperature limits: 15˚C-30˚C.
Stop Use And Ask A Doctor If
- redness, irritation, swelling or pain persists or increases
- infection occurs
Directions
Swab locally as needed.
Other Information
- 1% titratable iodine
- not made with natural rubber latex
- for hospital or professional use only
- store product upright
Inactive Ingredients
disodium phosphate, glycerin, hydroxyethylcellulose, nonoxynol-10, simethicone, water
Manufacturing Information
Made in USA by: Medline Industries, LP
Three Lakes Drive,
Northfield, IL 60093 USA.
REF: MDS1982
1-800-MEDLINE V2 RB24HND
www.medline.com
* Please review the disclaimer below.
