FDA Label for Sunmark Povidone-iodine Topical

View Indications, Usage & Precautions

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.


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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