PVP IODINE SWABS- povidone-iodine solution NORTH PVP IODINE SWABS- povidone-iodine solution

North PVP Iodine Swabs by

Drug Labeling and Warnings

North PVP Iodine Swabs by is a Otc medication manufactured, distributed, or labeled by Honeywell Safety Products USA, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Povidone-iodine solution USP, 10% (equivalent to 1% titratable iodine)

Purpose

First aid antiseptic

Uses

first aid to help prevent the risk of infection in minor cuts, scrapes, and burns

Warnings

For external use only

Do not use

• in the eyes
• over large areas of the body
• on individuals who are allergic or sensitive to iodine

Ask a doctor before use if you have

• deep or puncture wounds,
• animal bites
• serious burns

When using this product

do not use longer than one wek unless directed by a doctor

Stop use and ask a doctor if

• conditions persists or gets worse
• irritation and redness develops

Keep out of reach of children.

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

Directions

Reverse cardboard sleeve, then crush at dot between thumb and forefinger. Allow solution to saturate tip and apply solution to injury.

• clean affected area
• apply to affected area 1 to 3 times daily
• may be covered with a sterile bandage
• discard swab after single use

Other information

• store at room temperature away from light
• keep from freezing or excessive heat
• do not use if package is torn or open

Inactive ingredients

citric acid, disodium phosphate,nonoxynol-9, sodium hydroxide, water

Questions and comments?

800-430-5490

Principal Display Panel

Honeywell PVP

INGREDIENTS AND APPEARANCE

PVP IODINE SWABS 
povidone-iodine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0498-0128
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	0.006 g  in 0.6 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
PHOSPHATE ION (UNII: NK08V8K8HR)
WATER (UNII: 059QF0KO0R)
NONOXYNOL-9 (UNII: 48Q180SH9T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0498-0128-46	10 in 1 CARTON	09/21/2018
1	NDC: 0498-0128-00	0.6 mL in 1 AMPULE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		09/21/2018

NORTH PVP IODINE SWABS 
povidone-iodine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0498-0118
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	0.006 g  in 0.6 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
PHOSPHATE ION (UNII: NK08V8K8HR)
WATER (UNII: 059QF0KO0R)
NONOXYNOL-9 (UNII: 48Q180SH9T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0498-0118-46	10 in 1 CARTON	09/12/2012
1		0.6 mL in 1 AMPULE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		09/12/2012

Labeler - Honeywell Safety Products USA, Inc (079287321)

Registrant - Honeywell Safety Products USA, Inc (079287321)

Establishment
Name	Address	ID/FEI	Business Operations
Honeywell Safety Products USA, Inc		079287321	pack(0498-0118, 0498-0128)