POVIDONE IODINE- povidone-iodine swab

Povidone Iodine by

Drug Labeling and Warnings

Povidone Iodine by is a Otc medication manufactured, distributed, or labeled by Sion Biotext Medical Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Povidone Iodine 10%

Purpose

Antiseptic

Uses

• Antiseptic cleanser to help prevent 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 burns

Stop use and ask a doctor if

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

Keep out of reach of children

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

Directions

• Tear at notch
• Remove applicator
• Use only once

As a first aid antispetic

• Clean affected area
• apply 1-3 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

Nonoxynol-9, water

Principal Display Panel

NDC: 68786-130-01

50 Packets

Povidone-Iodine Swabsticks

Antispetic/Germicide

For External Use Only

Sion Biotext Medical Ltd.

INGREDIENTS AND APPEARANCE

POVIDONE IODINE 
povidone-iodine swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68786-130
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	0.10 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68786-130-01	50 in 1 BOX	04/17/2013
1		1 in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 68786-130-02	25 in 1 BOX	04/17/2013
2		3 in 1 PACKET; Type 0: Not a Combination Product
3	NDC: 68786-130-03	50 in 1 BOX	04/17/2013
3		1 in 1 PACKET; Type 0: Not a Combination Product
4	NDC: 68786-130-04	50 in 1 BOX	04/17/2013
4		1 in 1 PACKET; Type 0: Not a Combination Product
5	NDC: 68786-130-05	25 in 1 BOX	04/17/2013
5		3 in 1 PACKET; Type 0: Not a Combination Product
6	NDC: 68786-130-06	50 in 1 BOX	04/17/2013
6		1 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 not final	part333A	04/17/2013

Labeler - Sion Biotext Medical Ltd (532775194)

Registrant - Sion Biotext Medical Ltd (532775194)

Establishment
Name	Address	ID/FEI	Business Operations
Sion Biotext Mexico SAPI de CV		951575186	manufacture(68786-130)