LORIS POVIDONE-IODINE SOLUTION- povidone-iodine liquid

Loris Povidone-Iodine by

Drug Labeling and Warnings

Loris Povidone-Iodine by is a Otc medication manufactured, distributed, or labeled by LernaPharm Loris Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Povidone Iodine 10% w/v

Purpose

Antiseptic

Uses

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 in the eyes.
• Discontinue use if irritation and redness develop.
  

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.
• Apply with friction for 30 seconds.
• Do not blot or wipe away.
  

Other Information

Store at room temperature between 59-86oF (15-30oC). 1% titratable iodine. Latex free

Inactive Ingredients

Citric Acid, Glycerol, Nonoxynol-9, Purified Water, Sodium Hydroxide, Sodium Phosphate Dibasic

Questions or comments?

Call 1-866-322-4634, weekdays between 8:00 am and 6:00 pm EST

Principal Display Panel

Hold upright

Product # 119-XXU          NDC: 68356-119-XX

Loris Povidone-Iodine [Solution]

[TEAR OPEN]  [Tear here and pour]

Antiseptic

STERILE Solution

[Applicator is sterile] Unless package is opened or damaged

For hospital and professional use only

MANUFACTURED BY

LERNAPHARM (LORIS) INC.

2323 HALPERN, VILLE ST-LAURENT

QUEBEC, CANADA H4S 1S3

INGREDIENTS AND APPEARANCE

LORIS POVIDONE-IODINE  SOLUTION
povidone-iodine liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68356-119
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
NONOXYNOL-9 (UNII: 48Q180SH9T)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68356-119-02	22.5 mL in 1 POUCH; Type 0: Not a Combination Product	04/16/2013
2	NDC: 68356-119-06	2.6 mL in 1 PACKET; Type 0: Not a Combination Product	07/14/2017
3	NDC: 68356-119-07	2.6 mL in 1 PACKET; Type 0: Not a Combination Product	07/14/2017
4	NDC: 68356-119-01	3 in 1 POUCH	04/16/2013
4		2.5 mL in 1 APPLICATOR; Type 0: Not a Combination Product
5	NDC: 68356-119-03	1 in 1 POUCH	07/14/2017
5		2.5 mL in 1 APPLICATOR; 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	part333E	04/16/2013

Labeler - LernaPharm Loris Inc. (206940905)

Establishment
Name	Address	ID/FEI	Business Operations
LernaPharm Loris Inc.		206940905	manufacture(68356-119) , label(68356-119) , pack(68356-119) , sterilize(68356-119)