0012 Aplicare Povidone-Iodine Solution (non-sterile)

Aplicare by

Drug Labeling and Warnings

Aplicare 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]

APLICARE- povidone-iodine solution 
Aplicare Products, LLC

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0012 Aplicare Povidone-Iodine Solution (non-sterile)

Active Ingredient

Povidone-iodine USP 10% w/v

Purpose

Antiseptic

Uses

• for preparation of the skin prior to surgery
• helps reduce bacteria that potentially can cause skin infection

Warnings

For external use only

Do not use

• if allergic to iodine
• in the eyes or apply over large areas of the body
• in case of deep or puncture wounds, animals bites, or serious burns, consult a doctor

Discontinue use if

• irritation and redness develop.
• If condition persists for more than 72 hours consult a doctor

Avoid pooling beneath patient

Keep out of reach of children.

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

Directions

antiseptic skin preparation: apply locally as needed.

Other information

• 1% titratable iodine
• not made with natural rubber latex
• for hospital or professional use only
• protect from freezing, avoid excessive heat
• store at room temperature

Inactive ingredients

alkyl glucoside, citric acid, glycerin, hydroxyethyl cellulose, nonoxynol-10, potassium iodide, purified water, sodium hydroxide

Manufacturing information

www.medline.com ©2024 Medline Industries, LP

Aplicare is a registered trademark of Medline Industries, LP

Manufactured for Medline Industries, LP

Three Lakes Drive, Northfield, IL 60093 USA

1-800-MEDLINE Made in China. V1 RL24CZU

Package Label

APLICARE 
povidone-iodine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52380-0012
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
C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
NONOXYNOL-10 (UNII: K7O76887AP)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
GLYCERIN (UNII: PDC6A3C0OX)
CITRIC ACID (UNII: 2968PHW8QP)
POTASSIUM IODIDE (UNII: 1C4QK22F9J)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52380-0012-3	22.5 mL in 1 PACKET; Type 0: Not a Combination Product	12/01/2024	12/02/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	12/01/2024	12/02/2024

Labeler - Aplicare Products, LLC (081054904)

Registrant - Medline Industries, LP (025460908)

Revised: 12/2025

Document Id: 44e780cc-13fe-dd55-e063-6294a90ad46a

34390-5

Set id: 29049f69-1ffd-ca59-e063-6394a90a244f

Version: 3

Effective Time: 20251201