APLICARE POVIDONE-IODINE- povidone-iodine solution
Aplicare Products, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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1721 Aplicare Non-Sterile Povidone-iodine Prep Swabs, 10%

Active ingredient

Povidone-iodine 10%

(equivalent to 1% available iodine)

Purpose

Antiseptic

Use

antiseptic skin preparation
single use when used for patient preoperative skin preparation

Warnings

For external use only.

Do not use

in the eye
on individuals allergic or sensitive to iodine

Ask 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.

Directions

Reverse cardboard sleeve then crush at dot between thumb and forefinger
Allow solution to saturate tip
apply topically as needed

Other information

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

Manufacturing Information

Manufactured for:

Aplicare Products, LLC

550 Research Parkway, Meriden, CT 06450 USA

Made in USA

REF: APL82278

RA19J-A

Package Label

swab

box

APLICARE POVIDONE-IODINE
povidone-iodine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52380-1721
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
NONOXYNOL-10 (UNII: K7O76887AP)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52380-1721-1	0.65 mL in 1 PACKET; Type 0: Not a Combination Product	09/01/1998	11/06/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	09/01/1998	11/06/2022

Labeler - Aplicare Products, LLC (081054904)

Registrant - Medline Industries, LP (025460908)

Revised: 12/2021

Document Id: d218e293-3bde-1a46-e053-2995a90a2484

Set id: c1134f2a-ea36-43f7-a4a5-56c306a15eb1

Version: 7

Effective Time: 20211201

Aplicare Products, LLC