FDA Label for Aplicare Povidone-iodine

View Indications, Usage & Precautions

Aplicare Povidone-iodine Product Label

The following document was submitted to the FDA by the labeler of this product Aplicare Products, 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.

Active Ingredient



Povidone-iodine USP 10%


Purpose



Antiseptic


Use



antiseptic skin preparation


Directions



Apply locally as needed.


Warnings



  • For external use only

Otc - Do Not Use



  • Do not use if allergic to iodine or in the eyes

Otc - Ask Doctor



  • Ask a doctor before use if injuries are deep wounds, puncture wounds, or serious burns.

Otc - Stop Use



  • Stop use and ask a doctor if infection occurs or if redness, irritation, swelling or pain persists or increases.

Otc - Keep Out Of Reach Of Children



  • Keep out of reach of children. In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.

Storage And Handling



  • Avoid excessive heat. Store at room temperature.

Other Information



  • 1% titratable iodine
  • Not made with natural rubber latex
  • For hospital or professional use only

Inactive Ingredients



glycerin, polyethylene glycol, propylene glycol


Principal Display Panel - 1 Gram Ointment Packet



NDC 52380-0126-2
NPN 02076071

APLICARE

POVIDONE-IODINE
OINTMENT

ANTISEPTIC/Non-Sterile Solution

Net Wt. 1 gram

LOT


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