APLICARE POVIDONE-IODINE- povidone-iodine ointment
Aplicare Products, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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0126 Povidone-Iodine Ointment

Active Ingredient

Povidone-iodine USP 10%

Purpose

Antiseptic

Use

antiseptic skin preparation

Warnings

For external use only

Do not use

if allergic to iodine or in the eyes

Ask a doctor before use if injuries are

deep wounds, puncture wounds, or serious burns

Stop use and ask a doctor

if infection occurs or if redness, irritation, swelling or pain persists or increases.

Keep out of reach of children.

In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.

Avoid excessive heat. Store at room temperature.

Directions

Apply locally as needed.

Other Information

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

Inactive ingredients

glycerin, polyethylene glycol, propylene glycol

Package Label

PRINCIPAL DISPLAY PANEL - 1 gram Ointment Packet

APLICARE POVIDONE-IODINE
povidone-iodine ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52380-0126
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	10 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYETHYLENE GLYCOL 1450 (UNII: OJ4Z5Z32L4)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52380-0126-2	1 g in 1 PACKET; Type 0: Not a Combination Product	05/31/2017	12/31/2025

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	05/31/2017	12/31/2025

Labeler - Aplicare Products, LLC (081054904)

Registrant - Medline Industries, LP (025460908)