CURITY POVIDONE-IODINE SCRUB- 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.

----------

4892 Curity Povidone-Iodine Scrub

Active ingredient

Povidone-iodine USP 7.5%

Purpose

Antiseptic

Use

antiseptic skin preparation

Warnings

For external use only.
Avoid "pooling beneath patient. Prolonged exposure to wet solution may cause skin irritation.

Do not use

• if allergic to iodine
• in the eyes

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.

Directions

• apply locally as needed

Other information

• 0.75% titratable iodine
for hospital or professional use only
avoid freezing and excessive heat (above 104°F)
not made with natural rubber latex

Inactive ingredients

ammonium nonoxynol-4 sulfate, citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water

Manufacturing Information

Manufactured for:

Covidien LLC

15 Hampshire Street, Mansfield, MA 02048 USA

Made in USA with domestic and foreign materials

HP105790

REF: 41401

Package Label

Povidone Iodine Scrub

CURITY POVIDONE-IODINE SCRUB
povidone-iodine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52380-4892
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	7.86 g in 1 mL

Ingredient Name	Strength
Inactive Ingredients
AMMONIUM NONOXYNOL-4 SULFATE (UNII: 9HIA70O4J0)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
NONOXYNOL-9 (UNII: 48Q180SH9T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52380-4892-8	109 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/14/2018	07/01/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	01/01/1998	07/01/2021

Labeler - Aplicare Products, LLC (081054904)

Registrant - Medline Industries, LP (025460908)

Revised: 12/2021

Document Id: d27e607d-8ff8-14f8-e053-2a95a90a9672

Set id: 5d15edc6-5246-4c97-8fc7-bde5163643a3

Version: 4

Effective Time: 20211206

Aplicare Products, LLC