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 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

Warnings

For external use only

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

Avoid excessive heat. Store at room temperature.

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
  

Keep out of reach of children.

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

Directions

use sponge sticks to prep desired area

Other information

• 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:

800-633-5463

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

APLICARE POVIDONE-IODINE PAINT 
povidone-iodine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52380-0101
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: 52380-0101-5	2 mL in 1 PACKET; Type 0: Not a Combination Product	03/01/1992

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/01/1992

Labeler - Aplicare Products, LLC. (081054904)

Establishment
Name	Address	ID/FEI	Business Operations
Aplicare Products, LLC		081054904	manufacture(52380-0101)