FDA Label for Sunmark Povidone-iodine Topical
View Indications, Usage & Precautions
- 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:
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS:
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
- SUNMARK POVIDONE-IODINE 10% TOPICAL SOLUTION 8OZ (49348-622-37) | SUNMARK POVIDONE-IODINE 10% TOPICAL SOLUTION 16OZ (49348-622-38)
Sunmark Povidone-iodine Topical Product Label
The following document was submitted to the FDA by the labeler of this product Strategic Sourcing Services Llc. 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.
Sunmark Povidone-Iodine 10% Topical Solution
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)
* Please review the disclaimer below.