Sunmark Povidone-iodine Topical Solution
FDA Label NDC 49348-622
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Strategic Sourcing Services Llc for the product Sunmark Povidone-iodine Topical (NDC 49348-622). 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 sunmark povidone-iodine 10% topical solution, active ingredient, purpose, uses, warnings, do not:, stop use and consult a doctor if, ask a doctor in case of:, 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% (*Equivalent to 1% titratable Iodine)
Purpose
Antiseptic
Uses
First aid antiseptic to prevent infection in minor cuts, burns.
Warnings
For external use only.
Do Not:
- use in the eyes.
- use longer than 1 week unless directed by a doctor.
- use on individuals who are allergic or sensitive to iodine.
- apply over large areas of the body.
Stop Use And Consult A Doctor If
- condition persists or gets worse.
- irritation and redness develop and persist for more than 72 hours.
Ask A Doctor In Case Of:
- deep or puncture wounds
- animal bites
- serious burns.
Keep Out Of Reach Of Children.
In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.
Directions
- Clean the affected area
- Apply a small amount on the area 1 to 3 times daily.
- May be covered with a sterile bandage.
- If bandaged, let dry first.
Other Information
Store at room temperature, 20-25
0 C (68-77
0 F).
Inactive Ingredients:
Citric Acid, Disodium Phosphate, Glycerin, Nonoxynol-9, Sodium Hydroxide and Purified Water.
Package Label.Principal Display Panel
COMPARE TO BETADINE ACTIVE INGREDIENT* sunmark povidone-iodine 10% Topical Solution FIRST AID ANTISEPTIC 16 FL OZ (PT) 473mL *This product is not manufactured or distributed by Purdue Frederick, owner of the registered trademark Betadine
Sunmark Povidone-Iodine 10% Topical Solution 8Oz (49348-622-37) | Sunmark Povidone-Iodine 10% Topical Solution 16Oz (49348-622-38)
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