FDA.reportPublic FDA data

Hand Sanitizer Gel

Manufacturer
New Directions Aromatics Inc.
Effective date
2020-07-21
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 23:22:07

Label at a glance#

ProductHand Sanitizer Gel
Active ingredientALCOHOL
Label structure12 sections

Storage and handling

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

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Alcohol 65%. Purpose: Antiseptic

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame.

This product contains a chemical that is currently listed under California's Proposition 65.

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 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.

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.

STORAGE AND HANDLING SECTION

Store between 15-30C (59-86F)

Avoid freezing and excessive heat above 40C (104F)

INACTIVE INGREDIENT SECTION

Purified Water, Glycerin, Polyquaternium-37, Aloe Barbadensis Leaf Juice

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label_Hand Sanitizer Gel 473 mLLabel_Hand Sanitizer Gel 473 mL

NDC 473 mL: 74179-800-01

Label_Hand Sanitizer Gel 200LLabel_Hand Sanitizer Gel 200L

Label_Hand Sanitizer Gel Bulk Drug FactsLabel_Hand Sanitizer Gel Bulk Drug Facts

NDC 200L: 74179-800-02

Label_Hand Sanitizer Gel 1000L (264 gal)Label_Hand Sanitizer Gel 1000L (264 gal)

NDC 1000L: 74179-800-04

Label_Hand Sanitizer Gel 60 mLLabel_Hand Sanitizer Gel 60 mL

NDC 60 mL: 74179-800-05

Label_Hand Sanitizer Gel 240 mLLabel_Hand Sanitizer Gel 240 mL

NDC 240 mL: 74179-800-06

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
902574ethanol 65 % Topical GelPSN6
902574ethanol 0.65 ML/ML Topical GelSCD6
902574ethyl alcohol 65 % Topical GelSY6

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74179-800-012021-07-23C16284748780-1c7ccaba7-2a42-fd44-e053-dadaa90aa01bHand Sanitizer Gel
74179-800-022021-07-23C16284748780-1c7ccaba7-2a42-fd44-e053-dadaa90aa01bHand Sanitizer Gel
74179-800-042021-07-23C16284748780-1c7ccaba7-2a42-fd44-e053-dadaa90aa01bHand Sanitizer Gel
74179-800-052021-07-23C16284748780-1c7ccaba7-2a42-fd44-e053-dadaa90aa01bHand Sanitizer Gel
74179-800-062021-07-23C16284748780-1c7ccaba7-2a42-fd44-e053-dadaa90aa01bHand Sanitizer Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74179-800-01Hand Sanitizer Gel473 mL in 1 BOTTLEGEL4736
74179-800-02Hand Sanitizer Gel200000 mL in 1 DRUMGEL2000006
74179-800-04Hand Sanitizer Gel1000000 mL in 1 TANKGEL10000006
74179-800-05Hand Sanitizer Gel60 mL in 1 BOTTLEGEL606
74179-800-06Hand Sanitizer Gel240 mL in 1 BOTTLEGEL2406

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74179-800HAND SANITIZER GEL GEL [NEW DIRECTIONS AROMATICS INC.]6Legacy NDC, 5 package rows20200722_a36ad864-f131-8023-e053-2995a90a7727.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74179-80074179-800-01, 74179-800-02, 74179-800-04, 74179-800-05, 74179-800-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
POLYQUATERNIUM-37 (25000 MPA.S)31L31U8285IACT
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERINPDC6A3C0OXIACT

Source Document#

Source XML · Source PDF

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
aaf30840-d05c-79a7-e053-2a95a90aeac9a36ad864-f131-8023-e053-2995a90a77272020-07-21WarningsExact identifier
spl id: aaf30840-d05c-79a7-e053-2a95a90aeac9
spl set id: a36ad864-f131-8023-e053-2995a90a7727

Reported adverse events (FAERS/openFDA)#

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