FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Fareva Morton Grove, Inc.
Effective date
2020-11-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:32:49

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
  4. Sterile distilled water or boiled cold water.
  5. Acrylates/C10-30 Alkyl Acrylate Crosspolymer
  6. Butylene Glycol
  7. Aloe Barbadensis Leaf Juice
  8. Aminomethyl Propanol
  9. Titanium Dioxide
  10. 1,2-Hexanediol
  11. Agar
  12. Gellan Gum
  13. Calcium Alginate
  14. Ultramarines
  15. Phenoxyethanol
  16. Propylene Glycol
  17. Citric Acid
  18. Sodium Benzoate
  19. Potassium Sorbate

RECENT MAJOR CHANGES SECTION

Updated to match the ingredients in our formula.

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 77% 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.

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, Aminomethyl Propanol, Butylene Glycol, Calcium Alginate, Citric Acid, Fragrance (Parfum), Gellan Gum, Glycerin, Phenoxyethanol, Potassium Sorbate, Propylene Glycol, Sodium Benzoate, Titanium Dioxide (CI 77891), Ultramarines (CI 77007), Water (Aqua)

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

50 mL NDC: 72686-184-05

GARDENIAGARDENIA

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1788839ethanol 77 % Topical GelPSN1
1788839ethanol 0.77 ML/ML Topical GelSCD1
1788839ethanol 77 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72686-184-052022-01-28C16284748780-1d6a99b39-4991-a426-e053-dadaa90af4c2b339ae8e-8a8b-e70b-e053-2995a90aa9e0

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72686-184-05Hand Sanitizer50 mL in 1 TUBEGEL501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72686-184HAND SANITIZER (ALCOHOL) GEL [FAREVA MORTON GROVE, INC.]1Legacy NDC, 1 package rows20201104_b339ae8e-8a8b-e70b-e053-2995a90aa9e0.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72686-18472686-184-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER INTERPOLYMER TYPE A (55000 CPS)59TL3WG5COIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM BENZOATEOJ245FE5EUIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
AGAR, UNSPECIFIED89T13OHQ2BIACT
ALCOHOL3K9958V90MACTIB
PROPYLENE GLYCOL6DC9Q167V3IACT
POTASSIUM SORBATE1VPU26JZZ4IACT
GLYCERINPDC6A3C0OXIACT
FRAGRANCE FLORAL ORC0902236R66Z4YW3X0IACT
WATER059QF0KO0RIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
GELLAN GUM (LOW ACYL)7593U09I4DIACT
CALCIUM ALGINATE8P20S56HZIIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ALOE VERA LEAFZY81Z83H0XIACT
ULTRAMARINE BLUEI39WR998BIIACT

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
b3399bd5-8977-30fe-e053-2995a90a3b60b339ae8e-8a8b-e70b-e053-2995a90aa9e02020-11-03WarningsExact identifier
spl id: b3399bd5-8977-30fe-e053-2995a90a3b60
spl set id: b339ae8e-8a8b-e70b-e053-2995a90aa9e0

Reported adverse events (FAERS/openFDA)#

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