POVIDONE IODINE- povidone-iodine swab

Povidone Iodine by

Drug Labeling and Warnings

Povidone Iodine by is a Otc medication manufactured, distributed, or labeled by TwinMed LLC, Sion Biotext Mexico SAPI de CV. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Povidone Iodine 10%

Purpose

Antiseptic

Uses:

• First aid to help prevent skin infection in minor cuts, scrapes, and burns
• Patient preoperative skin preparation: Helps to reduce bacteria that potentially can cause skin infection.

Warnings:

For external use only.

Do not use:

• In the eyes
• Longer than one week unless directed by a doctor
• On individuals who are allergic or sensitive to iodine
• Or apply 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:

• 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 immediately.

Directions:

Tear at notch. Remove applicator. Discard applicator after single use.

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

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

Principal Display Panel

PROCURE

HEALTHCARE PRODUCTS

POVIDONE

IODINE

PREP PAD

Antiseptic

100 PADS

INGREDIENTS AND APPEARANCE

POVIDONE IODINE 
povidone-iodine swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55681-751
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	0.1 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55681-751-00	10 in 1 CASE	05/25/2023
1		100 in 1 BOX
1		0.1 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 Drug	M003	05/25/2023

Labeler - TwinMed LLC (009579330)

Registrant - TwinMed LLC (009579330)

Establishment
Name	Address	ID/FEI	Business Operations
Sion Biotext Mexico SAPI de CV		951575186	manufacture(55681-751)