Active Ingredient
Povidone Iodine 10%
Povidone Iodine Swab
FDA Label NDC 55681-751
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 55681-751). 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 skin 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 wounds
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.
As a first aid antispetic:
- Clean affected area
- Apply 1-3 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.
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
POVIDONE
IODINE
PREP PAD
Antiseptic
100 PADS
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