POVIDONE IODINE- povidone-iodine swab
Sion Biotext Medical 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

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.

Label

POVIDONE IODINE
povidone-iodine swab

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	0.1 g

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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	04/17/2013

Labeler - Sion Biotext Medical Ltd (532775194)

Registrant - Sion Biotext Medical Ltd (532775194)

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

Revised: 1/2022

Document Id: d4b20a4a-d28e-0463-e053-2a95a90ac0d3

Set id: 04438f9e-302c-431b-b3ad-d2c50ca01ad8

Version: 3

Effective Time: 20220103

Sion Biotext Medical Ltd