FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Fareva Morton Grove, Inc.
Effective date
2020-12-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:35:20

Label at a glance#

ProductHand 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

a. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (77%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
b. Glycerin

c. FRAGRANCE (PARFUM)
d. ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER
e. ALOE BARBADENSIS LEAF JUICE
f. AMINOMETHYL PROPANOL
g. YELLOW 5 (CI 19140)
h. CITRIC ACID
i. SODIUM BENZOATE
j. POTASSIUM SORBATE

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 78% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic

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.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation and redness develops and persists.

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 ingredients

INACTIVE INGREDIENT SECTION

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Aminomethyl Propanol, Citric Acid, Fragrance, Glycerin, Potassium Sorbate, Sodium Benzoate, Water, Yellow 5 (CI 19140)

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

50 mL NDC: 72686-187-05

garden_walk.jpggarden_walk.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72686-187-052022-01-28C16284748780-1d6a99b39-673b-a426-e053-dadaa90af4c2b6852ce4-6f35-37b9-e053-2a95a90a0afa

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72686-187-05Hand Sanitizer50 mL in 1 TUBEGEL501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72686-187HAND SANITIZER (ALCOHOL) GEL [FAREVA MORTON GROVE, INC.]1Legacy NDC, 1 package rows20201216_b6852ce4-6f35-37b9-e053-2a95a90a0afa.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72686-18772686-187-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
FRAGRANCE LEMON ORC2001060K1725A7G95IACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
SODIUM BENZOATEOJ245FE5EUIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
CARBOMER INTERPOLYMER TYPE A (55000 CPS)59TL3WG5COIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
ALOEV5VD430YW9IACT
POTASSIUM SORBATE1VPU26JZZ4IACT

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
b684d65a-02ac-61e6-e053-2a95a90a3aedb6852ce4-6f35-37b9-e053-2a95a90a0afa2020-12-15WarningsExact identifier
spl id: b684d65a-02ac-61e6-e053-2a95a90a3aed
spl set id: b6852ce4-6f35-37b9-e053-2a95a90a0afa

Reported adverse events (FAERS/openFDA)#

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