APLICARE POVIDONE-IODINE PAINT- povidone-iodine solution

Aplicare Povidone-Iodine Paint by

Drug Labeling and Warnings

Aplicare Povidone-Iodine Paint by is a Otc medication manufactured, distributed, or labeled by Aplicare, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Povidone-iodine USP 10%

Purpose

Antiseptic

Use

antiseptic skin preparation

Warnings

Do not use

• if allergic to iodine
• in the eyes

Ask a doctor before use if injuries are

• deep wounds
• puncture wounds
• serious burns

Stop use and ask a doctor if

• redness, irritation, swelling or pain persists or increases
• infection occurs

For external use only

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

Avoid pooling beneath the patient. Prolonged exposure to wet solution may cause skin irritation.

Avoid excessive heat. Store at room temperature.

Directions

use sponge sticks to prep desired area

Other information

• 1% titratable iodine
• for single use only
• not made with natural rubber latex
• for hospital or professional use only

Inactive ingredients

citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water

QUESTIONS

For questions, comments, or to report serious side effects:

800-760-3236

Monday-Friday 8:30 a.m.-5:00 p.m. EST

PRINCIPAL DISPLAY PANEL - 2 Sponge Sticks Packet

NDC: 52380-4011-2

APLICARE

◀ Tear Here   Hold Upright   Tear Here ▶

TWO POVIDONE-IODINE PAINT
SPONGE STICKS

ANTISEPTIC
Non-Sterile Solution

Two 8-inch Sponge Sticks Saturated with
Povidone-Iodine USP, 1% Available Iodine

Reorder No. F-2011

INGREDIENTS AND APPEARANCE

APLICARE POVIDONE-IODINE PAINT 
povidone-iodine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52380-4011
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 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
NONOXYNOL-9 (UNII: 48Q180SH9T)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52380-4011-2	2 mL 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, Inc. (107255002)

Establishment
Name	Address	ID/FEI	Business Operations
Aplicare, Inc.		107255002	manufacture(52380-4011)