Firstline Medical The I-stick Povidone-iodine Antiseptic Ampules
FDA Label NDC 41477-420
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by The Wild Side, Llc Dba Firstline Medical for the product Firstline Medical The I-stick Povidone-iodine Antiseptic Ampules (NDC 41477-420). 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 firstline medical the i-stick povidone-iodine antiseptic ampules, active ingredient, purpose, uses, warnings, do not use, when using this product, 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-iodine 10%
Purpose
Antiseptic
Uses
- Patient preoperative skin preparation
- For preparation of the skin prior to surgery
- Helps to reduce bacteria that potentially can cause skin infection
Warnings
For external use only.
Do Not Use
- in the eyes
When Using This Product
keep out of eyes, ears, and mouth
Stop Use And Ask A Doctor If
- irritation and redness develop
- condition persists for more than 72 hours
- infection occurs
Keep Out Of Reach Of Children.
- If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- clean the area
- reverse cardboard sleeve then crush at dot between thumb and forefinger
- allow solution to saturate tip
- apply product to the operative site prior to surgery using the applicator tip
Other Information
- Store at room temperature away from light
- Keep from freezing or excessive heat
Inactive Ingredients
- citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water
Questions?
call 1-866-433-2131 Monday through Friday 9:00am-5:00pm est
Line Medical The I-Stick Povidone-Iodine Antiseptic Ampules 25 Count (41477-420-69)
- Representative Package Labeling
Outerlabel (Outerlabel)
Innerlabel (Innerlabel)
Flyerlabel (Flyerlabel)
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