FDA Label for Povidone Iodine Prep
View Indications, Usage & Precautions
Povidone Iodine Prep Product Label
The following document was submitted to the FDA by the labeler of this product Cardinal Health. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
Povidone Iodine 10%
(equivalent to 1% titratable iodine)
Purpose
Antiseptic/First Aid Antispetic
Uses
- First aid to help prevent skin infection in minor cuts,scrapes, and burns
- For preparation of the skin prior to skin surgery
- Helps to reduce bacteria that can potentially cause skin infection
Warnings
For External Use Only.
Do Not Use
As a first aid antiseptic
- Do not use in the eyes or apply over large areas of the body
- In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor
- Stop use and consult a doctor if the condition persists or gets worse
- Do not use longer than 1 week unless directed by a doctor
- Do not use in the eyes
- Discontinue use if irritation and redness develop
- If condition persists for more than 72 hours, consult a doctor
For preoperative patient skin preparation
Keep Out Of Reach Of Children.
- If swallowed, get medical help or contact a Poison Control Center right away.
Directions:
Clean the affected area.
For preparation of skin prior to surgery
- Apply product to the operative site prior to surgery
- Apply a small amount of this product on the area 1-3 times daily.
- May be covered with a sterile bandage.
- If bandaged, let dry first.
For first aid antiseptic
Other Information
- Protect from freezing
- Avoid excessive heat
Inactive Ingredients:
Citric Acid, Disodium Phosphate, Nonoxynol-9, Sodium Hydroxide, Water
Principal Display Panel
Povidone-Iodine Prep Solution
Povidone-Iodine 10%
single use only
Cardinal Health
Net Wt. 0.75 fl oz (22.2 mL)
NDC 63517-132-01
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