Active ingredient

Povidone-iodine USP 10%

Purpose

Antiseptic

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 or 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.

Uses

antiseptic skin preparation
single use when used for patient preoperative skin preparation and/or preinjection indications.

Directions

apply locally as needed

Other information

1% titratable iodine
not made with Natural Rubber Latex
for hospital or professional use only

Inactive ingredients

• citric acid

• disodium phosphate

• nonoxynol-9

• sodium hydroxide

• water

Questions or comments?

1 800-633-5463

Monday - Friday

8:30 AM -5:00 PM EST

Manufacturing Information

Manufactured by:
Aplicare Products, LLC
550 Research Parkway, Meriden, CT 06450 USA

Made in USA with domestic and foreign materials
1-800-633-5463
REF: APL82332
RL17HND

Package Label

Label RL17HND

APLICARE POVIDONE-IODINE
povidone-iodine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52380-1905
Route of Administration	TOPICAL

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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52380-1905-2	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/01/1998	06/01/2022
2	NDC:52380-1905-4	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/01/1998	06/01/2022
3	NDC:52380-1905-8	240 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/01/1998	06/01/2022
4	NDC:52380-1905-6	480 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/01/1998	07/31/2021
5	NDC:52380-1905-7	960 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/01/1998	03/31/2022
6	NDC:52380-1905-9	3800 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/01/1998	06/01/2022
7	NDC:52380-1905-3	90 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/01/1998
8	NDC:52380-1905-0	60 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	09/01/1998

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	505G(a)(3)	09/01/1998

Labeler - Aplicare Products, LLC (081054904)

Registrant - Medline Industries, LP (025460908)

1905 10% PVP-I Scrub, Non-Sterile