Hand Sanitizer

Manufacturer
Fareva Morton Grove, Inc. | Fareva Richmond, Inc.
Effective date
2020-12-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:35:04

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure13 sections

Dosage and administration

Spray enough product on hands to cover all surfaces. Rub hands together until dry. For children under 6, use only under adult supervision. Updated due to product being an aerosol

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

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (78%, 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. Glycerin
  3. Sterile distilled water or boiled cold water.

.

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 78% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

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 develops and lasts.

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 develops and lasts.

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

  • Spray enough product on hands to cover all surfaces. Rub hands together until dry.
  • For children under 6, use only under adult supervision.

RECENT MAJOR CHANGES SECTION

Updated due to product being an aerosol

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, water

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

66 mL NDC: 72686-183-10

fridababy_2oz_BOV.jpg

fridababy_2oz_BOVfridababy_2oz_BOV

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2468411ethanol 78 % Topical SprayPSN1
2468411ethanol 0.78 ML/ML Topical SpraySCD1
2468411ethanol 78 % Topical SpraySY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72686-183-102022-01-28C16284748780-1d6a99b39-9ab9-a426-e053-dadaa90af4c2b59294dc-13ff-d848-e053-2a95a90a9c9a

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72686-183-10Hand Sanitizer66 mL in 1 CANAEROSOL, SPRAY661

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72686-183HAND SANITIZER (ALCOHOL) AEROSOL, SPRAY [FAREVA MORTON GROVE, INC.]1Legacy NDC, 1 package rows20201212_b59294dc-13ff-d848-e053-2a95a90a9c9a.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72686-18372686-183-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB

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
b5928f0a-8a40-6765-e053-2995a90a9011b59294dc-13ff-d848-e053-2a95a90a9c9a2020-12-03WarningsExact identifier
spl id: b5928f0a-8a40-6765-e053-2995a90a9011
spl set id: b59294dc-13ff-d848-e053-2a95a90a9c9a

Reported adverse events (FAERS/openFDA)#

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