APLICARE POVIDONE-IODINE- povidone-iodine ointment

Aplicare Povidone-Iodine by

Drug Labeling and Warnings

Aplicare Povidone-Iodine by is a Otc medication manufactured, distributed, or labeled by Aplicare Products, LLC, Medline Industries, LP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Povidone-iodine USP 10%

Purpose

Antiseptic

Use

antiseptic skin preparation

Directions

Apply locally as needed.

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.

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

INGREDIENTS AND APPEARANCE

APLICARE POVIDONE-IODINE 
povidone-iodine ointment

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

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

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

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

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

Labeler - Aplicare Products, LLC (081054904)

Establishment
Name	Address	ID/FEI	Business Operations
Aplicare Products, LLC		081054904	manufacture(52380-0126)