PARA-AID POVIDONE-IODINE PREP PADS- povidone iodine irrigant
Mcure Health Solutions Inc.

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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These highlights do not include all the information needed to use Povidone-Iodine Prep Pad. See full prescribing information for Povidone-Iodine Prep Pad.

Active Ingredient

Povidone Iodine 10%

Uses

For preparation of the skin prior to surgery

Warnings

For External Use Only

Flammable, keep away from fire or fame.

Do not use

in the eyes

Stop use

if irritation and redness develops

if condition persists for more than 72 hours, consult a physician

Keep out of reach of children

if swallowed, get medical help or contact a Poison Control Center right away

Directions

Wipe surgery site vigorously and discard.

Other information

Store at room temperature 15°-30°C (59°-86°F)

Inactive ingredients

Nonoxynol-9, water

DOSAGE & ADMINISTRATION

Sterile unless pouch is opened or damaged.

Saturated with 10% Povidone Iodine.

Purpose

Antiseptic

INDICATIONS & USAGE

First aid to help prevent infection in minor cuts, scrapes, and burns

Package.Label Principal Display Panel

Povidone-Iodine Prep Pad

1 Pad

Medium

img_2af85fb9-7b8d-57d6-e054-00144ff88e88

PARA-AID POVIDONE-IODINE PREP PADS
povidone iodine irrigant

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52486-001
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
WATER (UNII: 059QF0KO0R)
NONOXYNOL-9 (UNII: 48Q180SH9T)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52486-001-01	10 mL in 1 PACKET; Type 0: Not a Combination Product	02/04/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	02/02/2016

Labeler - Mcure Health Solutions Inc. (053034873)

Registrant - Mcure Health Solutions Inc. (053034873)

Name	Address	ID/FEI	Business Operations
Establishment
Taizhou Kangping Medical Science And Technology Co., Ltd		543429840	manufacture(52486-001)

Revised: 10/2019

Document Id: 96039de2-faec-5228-e053-2a95a90a74e3

Set id: 2ad05cb6-8663-3474-e054-00144ff88e88

Version: 2

Effective Time: 20191028

Mcure Health Solutions Inc.