FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Fareva Morton Grove, Inc.
Effective date
2020-12-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:35:17

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

  1. 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.
  2. Glycerin
  3. FRAGRANCE (PARFUM)
    d. ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER
    e. BUTYLENE GLYCOL
    f. ALOE BARBADENSIS LEAF JUICE
    g. AMINOMETHYL PROPANOL
    h. 1,2-HEXANEDIOL
    i. AGAR
    j. GELLAN GUM
    k. CALCIUM ALGINATE
    l. PHENOXYETHANOL
    m. PROPYLENE GLYCOL
    n. PIGMENT RED 5 (CI 12490)
    o. CITRIC ACID
    p. SODIUM BENZOATE
    q. POTASSIUM SORBATE

RECENT MAJOR CHANGES SECTION

Content was updated to match the final formula.

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 77% 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

1,2-Hexanediol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Agar, Aloe Barbadensis Leaf Juice, Alpha-Isomethyl Ionone,
Aminomethyl Propanol, Butylene Glycol, Calcium Alginate, Citric Acid, Fragrance (Parfum), Gellan Gum, Glycerin, Phenoxyethanol, Pigment Red 5 (Ci 12490, Potassium Sorbate, Propylene Glycol, Sodium Benzoate, Water (Aqua)

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

50 mL NDC: 72686-186-05

SunnyOrangeSunnyOrange

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1788839ethanol 77 % Topical GelPSN2
1788839ethanol 0.77 ML/ML Topical GelSCD2
1788839ethanol 77 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72686-186-052022-01-28C16284748780-1d6a99b39-4cae-a426-e053-dadaa90af4c2b33b0451-0237-20e5-e053-2a95a90aeed6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72686-186-05Hand Sanitizer50 mL in 1 TUBEGEL502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72686-186HAND SANITIZER (ALCOHOL) GEL [FAREVA MORTON GROVE, INC.]2Legacy NDC, 1 package rows20201216_b33b0451-0237-20e5-e053-2a95a90aeed6.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72686-18672686-186-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
PHENOXYETHANOLHIE492ZZ3TIACT
PIGMENT RED 591OZU993LXIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM BENZOATEOJ245FE5EUIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
ALOEV5VD430YW9IACT
AMINOMETHYLPROPANOLLU49E6626QIACT
GELLAN GUM (LOW ACYL)7593U09I4DIACT
CALCIUM ALGINATE8P20S56HZIIACT
CARBOMER INTERPOLYMER TYPE A (55000 CPS)59TL3WG5COIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
1,2-HEXANEDIOLTR046Y3K1GIACT
AGAR89T13OHQ2BIACT
GLYCERINPDC6A3C0OXIACT
FRAGRANCE ORANGE ORC2000765GX5JI7UXQ7IACT
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
b686b8f2-9259-f1cb-e053-2995a90aad52b33b0451-0237-20e5-e053-2a95a90aeed62020-12-15WarningsExact identifier
spl id: b686b8f2-9259-f1cb-e053-2995a90aad52
spl set id: b33b0451-0237-20e5-e053-2a95a90aeed6

Reported adverse events (FAERS/openFDA)#

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