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 59-86 oF (15-30 oC). 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

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

Loris Povidone-Iodine [Solution]

[TEAR OPEN] [Tear here and pour]

[Three 4-inch antiseptic swabsticks impregnated with 10% W/V povidone iodine solution]

[0.75 Fl. oz (22.5 mL)]

Antiseptic Solution

For hospital and professional use only

MANUFACTURED BY

LERNAPHARM (LORIS) INC.

2323 HALPERN, VILLE ST-LAURENT

QUEBEC, CANADA H4S 1S3

image of 68356-119-01

image of 68356-119-02

LORIS POVIDONE-IODINE SOLUTION
povidone-iodine liquid

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

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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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	07/20/2022
3	NDC:68356-119-07	2.6 mL in 1 PACKET; Type 0: Not a Combination Product	07/14/2017	07/20/2022
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	07/20/2022
5		2.5 mL in 1 APPLICATOR; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	505G(a)(3)	04/13/2013

Labeler - LernaPharm Loris Inc. (206940905)

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

Drug Facts