LORIS 7.5% POVIDONE-IODINE AND 74% ISOPROPYL ALCOHOL SOLUTION- povidone-iodine and isopropyl alcohol liquid

Loris 7.5% Povidone-Iodine and 74% Isopropyl Alcohol by

Drug Labeling and Warnings

Loris 7.5% Povidone-Iodine and 74% Isopropyl Alcohol by is a Otc medication manufactured, distributed, or labeled by LernaPharm Loris Inc., STERIS Isomedix Services. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Povidone Iodine 7.5% w/v

Isopropyl Alcohol 74% v/v

Purpose

Antiseptic

Uses

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

Warnings

• Flammable, keep away from fire or flame.
• Do not use with electrocautery procedures.
• 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.
• Allow to dry.
• Do not blot or wipe away.

Other Information

Store at room temperature between 59-86 oF (15-30 oC)

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

Prod. #: 121-01U          NDC: 68356-121-XX

LORIS

Applicator containing a solution of 7.5% w/v Povidone-Iodine & 74% v/v Isopropyl Alcohol

Net content: 0.9 fl. oz (26 mL)

Antiseptic

STERILE Solution and Swab

Unless package is opened or damaged

For Hospital and Professional Use Only

MANUFACTURED BY:

LERNAPHARM (LORIS) INC.

VILLE ST-LAURENT

QC, CANADA H4S 1S3

LOT #: (XXXX)          EXP.: (MM-YYYY)

INGREDIENTS AND APPEARANCE

LORIS 7.5% POVIDONE-IODINE AND 74% ISOPROPYL ALCOHOL  SOLUTION
povidone-iodine and isopropyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68356-121
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	75 g  in 1 mL
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	0.74 mL  in 1 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: 68356-121-01	1 in 1 POUCH	01/11/2016
1		26 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	01/11/2016

Labeler - LernaPharm Loris Inc. (206940905)

Establishment
Name	Address	ID/FEI	Business Operations
STERIS Isomedix Services		205475333	sterilize(68356-121)

Establishment
Name	Address	ID/FEI	Business Operations
LernaPharm Loris Inc.		206940905	manufacture(68356-121) , label(68356-121) , pack(68356-121)