CURITY POVIDONE-IODINE ONE-STEP PREP- povidone-iodine gel

Curity Povidone-Iodine One-Step Prep by

Drug Labeling and Warnings

Curity Povidone-Iodine One-Step Prep 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]

Active ingredient

Povidone-iodine USP 10 percent

Purpose

Antiseptic

Use

antiseptic skin preparation

Warnings

Do not use if allergic to iodine.

For external use only.

Ask a doctor before use if injuries are

• deep or puncture wounds
• serious burns

Do not use in eyes.

Avoid "pooling beneath patient. Prolonged exposure to wet solution may cause skin irritation.

STOP USE

Stop use and ask a doctor if

• infection occurs
• redness, irritation, swelling or pain persists or increases

KEEP OUT OF REACH OF CHILDREN

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

Inactive ingredients

Disodium phosphate, glycerin, hydroxyethylcellulose, nonoxynol-10, simethicone, water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CURITY POVIDONE-IODINE ONE-STEP PREP 
povidone-iodine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52380-4193
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	9.7 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
GLYCERIN (UNII: PDC6A3C0OX)
CETYL HYDROXYETHYLCELLULOSE (550000 MW) (UNII: 2MIM45ZIL3)
NONOXYNOL-10 (UNII: K7O76887AP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52380-4193-8	109 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/14/2018	07/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/01/1998	07/01/2022

Labeler - Aplicare Products, LLC. (081054904)

Establishment
Name	Address	ID/FEI	Business Operations
Aplicare Products, LLC.		081054904	manufacture(52380-4193)