FDA.reportPublic FDA data

Loris 7.5% Povidone-Iodine and 74% Isopropyl Alcohol

Manufacturer
LernaPharm Loris Inc. | STERIS Isomedix Services
Effective date
2019-10-23
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 00:06:15

Label at a glance#

ProductLoris 7.5% Povidone-Iodine and 74% Isopropyl Alcohol Solution
Active ingredientPOVIDONE-IODINE, ISOPROPYL ALCOHOL
Label structure9 sections

Indications and uses

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

Dosage and administration

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.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Povidone Iodine 7.5% w/v

Isopropyl Alcohol 74% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

  • Flammable, keep away from fire or flame.
  • Do not use with electrocautery procedures.
  • For External Use Only

SPL UNCLASSIFIED SECTION

  • Do not use in the eyes.
  • Discontinue use if irritation and redness develop.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

SPL UNCLASSIFIED SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

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

Principal Display Panel

PACKAGE LABEL.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)

image of applicator tube labelimage of applicator tube label

image of applicator envelope labelimage of applicator envelope label

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68356-12168356-121-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
GLYCERINPDC6A3C0OXIACT
NONOXYNOL-948Q180SH9TIACT
WATER059QF0KO0RIACT
SODIUM HYDROXIDE55X04QC32IIACT
SODIUM PHOSPHATE, DIBASICGR686LBA74IACT
POVIDONE-IODINE85H0HZU99MACTIM
ISOPROPYL ALCOHOLND2M416302ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
e4551901-31e8-8db9-e053-2a95a90a37e470c7b7ff-56da-4de5-a5c6-2dfd16cd2eef2022-07-21WarningsExact identifier
spl set id: 70c7b7ff-56da-4de5-a5c6-2dfd16cd2eef

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.