POVIDONE IODINE PREP PAD- antiseptic swab

Povidone Iodine Prep Pad by

Drug Labeling and Warnings

Povidone Iodine Prep Pad by is a Otc medication manufactured, distributed, or labeled by Dynarex Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Povidone iodine USP 10%

Purpose

Antiseptic

Uses

• Antiseptic cleanser to help prevent skin infection in minor cuts, scrapes and burns
• For preparation of the skin prior to surgery
• Helps reduce bacteria that can potentially cause skin infection

Warnings

For External Use Only

Do not use

• In the eyes
• As a first aid antiseptic for more than 1 week
• Over large areas of the body

Ask a doctor before use if you have

• Deep or puncture wounds
• Animal bites
• Serious wounds

Stop use and ask a doctor if

• Condition worsens or persists for more than 72 hours
• Irritation or redness develops

If swallowed, get medical help or contact a Poison Control Center immediately

Directions

• Tear at notch
• Remove applicator
• Use only once

As a first aid antiseptic

• Clean affected area
• Apply 1 to 3 times daily
• May be covered with a sterile bandage
• If bandaged, let dry first

For preoperative patient skin preparation

• Clean area
• Apply to operative site prior to surgery using applicator

Other Information

• Store at room temperature
• Avoid excessive heat

Inactive Ingredients

Citric Acid, Glycerin, Polysorbate 80 (Tween 80), Sodium Citrate USP, Sodium Phosphate Dibasic, Water

Label

INGREDIENTS AND APPEARANCE

POVIDONE IODINE PREP PAD 
antiseptic swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67777-002
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
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
WATER (UNII: 059QF0KO0R)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67777-002-01	1000 in 1 CASE	12/17/2018
1		100 in 1 BOX
1		0.3 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	12/17/2018

Labeler - Dynarex Corporation (008124539)