POVIDONE-IODINE solution

Povidone-Iodine by

Drug Labeling and Warnings

Povidone-Iodine by is a Otc medication manufactured, distributed, or labeled by Smiths Medical ASD, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Povidone-Iodine

KEEP OUT OF REACH OF CHILDREN

In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.

INDICATIONS & USAGE

Antiseptic skin preparation

WARNINGS

Do not use if allergic to iodine

For external use only

Ask a doctor before use if injuries are

• deep or punture wounds
• serious burns

Stop use and ask a doctor if

• redness, irritation, swelling or pain persists or increases
• infection occurs

Do not use in eyes

Avoid pooling beneath patient

Keep out of reach of children

In case of accidental ingestion, seek professional assistance or consult a poison
control center immediately.

DOSAGE & ADMINISTRATION

Apply locally as needed

INACTIVE INGREDIENT

citric acid, disodium phosphate,

nonoxynol-9, sodium hydroxide, water

PRINCIPAL DISPLAY PANEL

Povidone Packet image.jpg

PURPOSE

Antiseptic

INGREDIENTS AND APPEARANCE

POVIDONE-IODINE 
povidone-iodine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51688-5473
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Povidone-Iodine (UNII: 85H0HZU99M) (Povidone-Iodine - UNII:85H0HZU99M)	Povidone-Iodine	9.8 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Sodium Phosphate, DIBASIC (UNII: GR686LBA74)
Sodium Hydroxide (UNII: 55X04QC32I)
Nonoxynol-9 (UNII: 48Q180SH9T)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51688-5473-2	9.8 g in 1 PACKET

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/03/1984

Labeler - Smiths Medical ASD, INC (137835299)