Active Ingredient
Povidone Iodine, 10% (equivalent 1% titratable Iodine)
Povidone Iodine Swab
FDA Label NDC 55681-753
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Twinmed Llc for the product Povidone Iodine (NDC 55681-753). 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 you have:, stop use and ask a doctor if:, keep out of reach of children:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antiseptic
Uses:
- First aid to help prevent infection in minor cuts, scrapes and burns
- Patient preoperative skin preparation.Helps to reduce bacteria that potentially can cause skin infection.
Warnings:
For external use only.
Do Not Use:
- In the eyes
- Longer than one week unless directed by a doctor
- On individuals who are allergic or sensitive to iodine
- Or apply over large areas of the body
Ask A Doctor Before Use If You Have:
- Deep or puncture wounds
- Animal bites
- Serious burns
Stop Use And Ask A Doctor If:
- Irritation and redness develops
- If condition persists for more than 72 hours, consult a physician.
Keep Out Of Reach Of Children:
If swallowed, get medical help or contact a Poison Control Center immediately.
Directions:
- Tear at notch
- Remove applicator
- Discard applicator after single use.
- Clean affected area
- Apply 1 to 3 times daily.
- May be covered with a sterile bandage
- If bandaged, let dry first.
- Clean area
- Apply to operative site prior to surgery using applicator.
As a first aid antispetic
For preoperative patient skin preparation:
Other Information:
- Store at room temperature
- Avoid excessive heat
Inactive Ingredients:
Citric Acid, Glycerin, Polysorbate 80 (Tween 80), Sodium Citrate UPS, Sodium Phosphate Dibasic, Water
Principal Display Panel
PROCURE
HEALTHCARE PRODUCTS
Triple Pack
POVIDONE IODINE
SWABSTICKS
Antiseptic
25 Swabsticks Per Box
10 Boxes Per Case
250 Swabstick Packs Total
* Please review the disclaimer below.
