Aplicare Povidone-Iodine
4801 Aplicare Povidone-Iodine
91aef86d-ce8b-45be-bce9-74450292e0cd
HUMAN OTC DRUG LABEL
Sep 2, 2025
Aplicare Products, LLC
DUNS: 081054904
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Povidone-Iodine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (6)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Package Label
INDICATIONS & USAGE SECTION
Use
- • antiseptic skin preparation
- • single use when used for patient preoperative skin preparation
OTC - PURPOSE SECTION
Purpose
Antiseptic
OTC - ACTIVE INGREDIENT SECTION
Active ingredient
Povidone-iodine 10%
(equivalent to 1% available iodine)
WARNINGS SECTION
Warnings
*For external use only *Avoid "pooling" beneath patient. Prolonged exposure to wet solution may cause skin irritation.
Do not use
- • in the eyes
- • on individuals allergic or sensitive to iodine
Ask a doctor before use if injuries are
- • deep puncture wounds
- • serious burns
Stop use and ask a doctor if
- • infection occurs
- • 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.
DOSAGE & ADMINISTRATION SECTION
Directions
apply topically as needed
OTHER SAFETY INFORMATION
Other information
- • not made with natural rubber latex
- • for hospital or professional use only
INACTIVE INGREDIENT SECTION
Inactive ingredients
citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water
OTC - QUESTIONS SECTION
Questions or comments?
www.medline.com 1 800-Medline
SPL UNCLASSIFIED SECTION
Manufacturing Information
Manufactured in USA by Medline Industries, LP,
Three Lakes Drive, Northfield, IL 60093 USA.
www.medline.com 1-800-Medline
REF: APL82344K
V1 RG24HND