INO MED 2 Hand Sanitizer

Manufacturer
GROUPE DISSAN, LE | Normand Robichaud Services conseils Inc.
Effective date
2020-06-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:17:56

Label at a glance#

ProductINO MED 2 Hand Sanitizer
Active ingredientALCOHOL
Label structure13 sections

Dosage and administration

Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Storage and handling

Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerol (1.45% v/v).
  3. Hydrogen peroxide (0.125% v/v).
  4. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 80% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame

Do not use

OTC - DO NOT USE SECTION

  • in children less than 2 months of age
  • on open skin wounds

OTC - WHEN USING SECTION

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

STORAGE AND HANDLING SECTION

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

INACTIVE INGREDIENT SECTION

SQUALANE GW89575KF9 IACT
PANTHENOL WV9CM0O67Z IACT
AMINOMETHYLPROPANOL LU49E6626Q IACT
INULIN JOS53KRJ01 IACT
CARBOMER INTERPOLYMER TYPE A (55000 CPS) 59TL3WG5CO IACT
LIMONENE, (+)- GFD7C86Q1W IACT
ALPHA-TOCOPHEROL ACETATE 9E8X80D2L0 IACT
GLYCERIN PDC6A3C0OX IACT
WATER 059QF0KO0R IACT
HYALURONATE SODIUM YSE9PPT4TH IACT
FRUCTOSE, DL- 02T79V874P IACT

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3.78 label3.78 label1 L label1 L label500 mL label500 mL label100 mL label100 mL label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1305100ethanol 75 % Topical GelPSN1
1305100ethanol 0.75 ML/ML Topical GelSCD1
1305100ethanol 75 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78306-501-112022-01-28C16284748780-1d6a99b39-5abc-a426-e053-dadaa90af4c2INO-MED2
78306-501-122022-01-28C16284748780-1d6a99b39-5abc-a426-e053-dadaa90af4c2INO-MED2
78306-501-142022-01-28C16284748780-1d6a99b39-5abc-a426-e053-dadaa90af4c2INO-MED2
78306-501-152022-01-28C16284748780-1d6a99b39-5abc-a426-e053-dadaa90af4c2INO-MED2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78306-501-11INO MED 2 Hand Sanitizer100 mL in 1 BOTTLE, PUMPGEL1001
78306-501-12INO MED 2 Hand Sanitizer500 mL in 1 BOTTLE, PUMPGEL5001
78306-501-14INO MED 2 Hand Sanitizer1000 mL in 1 BOTTLE, PUMPGEL10001
78306-501-15INO MED 2 Hand Sanitizer3800 mL in 1 BOTTLE, PUMPGEL38001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78306-501INO MED 2 HAND SANITIZER (ALCOHOL) GEL [GROUPE DISSAN, LE]1Legacy NDC, 4 package rows20200617_a7fdcad6-2fd5-2550-e053-2a95a90a1e70.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78306-50178306-501-12, 78306-501-14, 78306-501-11, 78306-501-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

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
a7fdcad6-2fc7-2550-e053-2a95a90a1e70a7fdcad6-2fd5-2550-e053-2a95a90a1e702020-06-13WarningsExact identifier
spl id: a7fdcad6-2fc7-2550-e053-2a95a90a1e70
spl set id: a7fdcad6-2fd5-2550-e053-2a95a90a1e70

Reported adverse events (FAERS/openFDA)#

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