PARA-AID POVIDONE-IODINE PREP PADS- povidone iodine irrigant

PARA-AID Povidone-Iodine Prep Pads by

Drug Labeling and Warnings

PARA-AID Povidone-Iodine Prep Pads by is a Otc medication manufactured, distributed, or labeled by Mcure Health Solutions Inc., Taizhou Kangping Medical Science And Technology Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

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

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
NONOXYNOL-9 (UNII: 48Q180SH9T)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

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

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

Labeler - Mcure Health Solutions Inc. (053034873)

Registrant - Mcure Health Solutions Inc. (053034873)

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