POVIDONE IODINE- povidone iodine 10% ointment

Povidone Iodine by

Drug Labeling and Warnings

Povidone Iodine by is a Otc medication manufactured, distributed, or labeled by Trifecta Pharmaceuticals USA LLC, Trifecta Pharmaceuticals USA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Povidone Iodine USP 10%

w/w (available iodine 1%)

Purpose

First Aid Antiseptic

Uses

First Aid to help prevent infection in minor cuts, scrapes and burns.

Warnings

For external Use Only

Do not use

• in eyes
• over large areas of the body
• if you are allergic to any of the ingredients

Directions

• Clean the affected area
• apply a small amount of this product (equal to the surface area of a fingertip) to the area 1 to 3 times daily.
• may be covered with a sterile bandage

Ask Doctor before use if you have

• deep or puncture wounds
• animal bites
• serious burns

Inactive Ingredients

Polyethylene glycol 400, Polyethylene glycol 4000

Questions?

Call 1-888-296-9067

Stop Use and Ask a doctor if

• The condition persists or gets worse
• you need to use this product for more than 1 week

Storage Information

• Store at controlled room temperature 20º to 25ºC (68ºF to 77ºF).
• close cap tightly after use.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1222) right away.

Questions

1-888-296-9067

Other Information

Distributed By:

Trifecta Pharmaceuticals USA®

101 NE Third Ave. Ste 1500

Ft. Lauderdale, FL. 33301 USA

www.trifecta-pharma.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

POVIDONE IODINE 
povidone iodine 10% ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69396-112
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	100 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69396-112-20	1 in 1 BOX	12/23/2022
1		28.3 g in 1 TUBE; 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	12/23/2022

Labeler - Trifecta Pharmaceuticals USA LLC (079424163)

Registrant - Trifecta Pharmaceuticals USA (079424163)