Povidone-Iodine Prep Pad Sterile

Prep Pad Sterile by

Drug Labeling and Warnings

Prep Pad Sterile by is a Otc medication manufactured, distributed, or labeled by Changzhou Maokang Medical Products Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PREP PAD STERILE- povidone-iodine patch 
Changzhou Maokang Medical Products Co., Ltd

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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Povidone-Iodine Prep Pad Sterile

Drug Facts

Active ingredient

Povidone-lodine 10%w/w

Purpose

Antiseptic

Use

Antiseptic for preparation of the skin.

Warnings

• For external use only.
• Discontinue use if irritation and redness develop.

Keep out of reach of children.

Driections

• Open packet and use as a washcloth.

Other information

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

Inactive ingredients:

Citrc Acid, Alkyl Glucoside, Hydroxyethy, Cellulose, Nonoxynol-10, Glycerin, Sodium Hydroxide, Potassium lodide, Purifed Water.

Package Labeling:

PREP PAD STERILE 
povidone-iodine patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59050-456
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16)
C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
NONOXYNOL-10 (UNII: K7O76887AP)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
POTASSIUM IODIDE (UNII: 1C4QK22F9J)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59050-456-11	5.5 g in 1 POUCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)	06/29/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	06/29/2018

Labeler - Changzhou Maokang Medical Products Co., Ltd (421317073)

Establishment
Name	Address	ID/FEI	Business Operations
Changzhou Maokang Medical Products Co., Ltd		421317073	manufacture(59050-456)

Revised: 9/2018

Document Id: 758abf53-ad8b-62ac-e053-2991aa0a8f0c

34390-5

Set id: 758abf53-ad8a-62ac-e053-2991aa0a8f0c

Version: 1

Effective Time: 20180910

 

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