FDA.reportPublic FDA data

Novuly Hand Sanitizer Gel (1 Gal, 3.79L)

Manufacturer
Big D of Kalamazoo, LLC
Effective date
2021-02-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:38:04

Label at a glance#

ProductNovuly Hand Sanitizer
Active ingredientALCOHOL
Label structure12 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#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 75% 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.

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 ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin, Squalane, Panthenol, Inulin, Sodium Hyaluronate, Fructose, Tocopheryl Acetate, Acrylates/C10-30 Alkyl Acrylate Cross Polymer, Aminomethyl Propanol

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1Gal (3.79L) NDC:80881-001-01

Manufacturer Information:

Made In China

Distributed by:
Big D of Kalamazoo, LLC
4339 Lakeside Dr
Kalamazoo, MI 49008
FDA
Labeler Code # 80881

Label 1Label 1

label 1label 1

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
80881-001-012023-01-30C16284748780-1f386c649-a1f8-0266-e053-dadaa90a7c1aNovuly Hand Sanitizer Gel (1 Gal, 3.79L)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80881-001-01Novuly Hand Sanitizer3.79 L in 1 JUGGEL3.791

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80881-001NOVULY HAND SANITIZER (ALCOHOL) GEL [BIG D OF KALAMAZOO, LLC]1Legacy NDC, 1 package rows20210212_baff32f8-be50-7a70-e053-2995a90a3a1b.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
80881-00180881-001-01

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
PANTHENOLWV9CM0O67ZIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
FRUCTOSE6YSS42VSEVIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
AMINOMETHYL PROPANEDIOLCZ7BU4QZJZIACT
PEG-9 DIGLYCIDYL ETHER/SODIUM HYALURONATE CROSSPOLYMER788QAG3W8AIACT
CARBOMER COPOLYMER TYPE A71DD5V995LIACT
SQUALENE7QWM220FJHIACT
INULINJOS53KRJ01IACT

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
baff32f8-be42-7a70-e053-2995a90a3a1bbaff32f8-be50-7a70-e053-2995a90a3a1b2021-02-10WarningsExact identifier
spl id: baff32f8-be42-7a70-e053-2995a90a3a1b
spl set id: baff32f8-be50-7a70-e053-2995a90a3a1b

Reported adverse events (FAERS/openFDA)#

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