DYNAREX POVIDONE IODINE PREP SOLUTION- povidone iodine prep solution liquid

Dynarex Povidone Iodine Prep Solution by

Drug Labeling and Warnings

Dynarex Povidone Iodine Prep Solution by is a Otc medication manufactured, distributed, or labeled by Dynarex Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Povidone-iodine 10%

Purpose

Healthcare Antiseptic

Use

For preparation of the skin prior to surgery. Helps reduce bacteria that potentially can cause skin infection

Warnings

For external use only

Do Not Use

• if allergic to iodine
• in the eyes

Stop use and ask a doctor if

• irritation and redness develop
• condition persists for more than 72 hours

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Clean the area. Apply product to the operative site prior to surgery.

Other

Store at controlled room temperature.

Inactive Ingredients

Citric Acid, Disodium Phosphate, Glycerin, Puried Water, Sodium Citrate, Tween 80

Questions?

1-888-DYNAREX

Labeling

INGREDIENTS AND APPEARANCE

DYNAREX POVIDONE IODINE PREP SOLUTION 
povidone iodine prep solution liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67777-141
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
WATER (UNII: 059QF0KO0R)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SODIUM PHOSPHATE (UNII: SE337SVY37)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67777-141-30	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/08/2018
2	NDC: 67777-141-40	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/08/2018
3	NDC: 67777-141-50	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/08/2018
4	NDC: 67777-141-60	3790 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/08/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	05/08/2018

Labeler - Dynarex Corporation (008124539)