DYNAREX POVIDONE IODINE PREP SOLUTION- povidone iodine prep solution liquid
Dynarex Corporation

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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1413, 1414, 1415, 1416

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

1413 Label

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

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

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:67777-141-31	48 in 1 CASE	05/08/2018
1	NDC:67777-141-30	118 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:67777-141-41	24 in 1 CASE	05/08/2018
2	NDC:67777-141-40	237 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC:67777-141-51	24 in 1 CASE	05/08/2018
3	NDC:67777-141-50	473 mL in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC:67777-141-61	4 in 1 CASE	05/08/2018
4	NDC:67777-141-60	3790 mL in 1 BOTTLE; Type 0: Not a Combination Product

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

Labeler - Dynarex Corporation (008124539)