FDA.reportPublic FDA data

Ellipse Hand Sanitizer

Manufacturer
Genomma Lab USA
Effective date
2021-07-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:39:44

Label at a glance#

ProductEllipse Hand Sanitizer Coconut Scent
Active ingredientALCOHOL
Label structure11 sections

Indications and uses

To decrease Bacteria on the skin when water, soap & towel are not available Recommended for repeated use.

Dosage and administration

Apply enough product to wet hands. Rub hands together until dry. Supervise children in use of this product.

Storage and handling

Do not store above 105 °F (40 °C) May discolor certain fabrics and wood surfaces.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70 % v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • To decrease Bacteria on the skin when water, soap & towel are not available
  • Recommended for repeated use.

Warnings

WARNINGS SECTION

  • For external use only
  • Flammable. Keep away from fire or flame.

When using this product

OTC - WHEN USING SECTION

  • Keep out of eyes. In case of contact with eyes, rinse eyes thoroughly with water
  • Do not use on broken or irritated skin.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or redness develop and last more than 72 hours.

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

  • Apply enough product to wet hands. Rub hands together until dry. Supervise children in use of this product.

Other information

STORAGE AND HANDLING SECTION

  • Do not store above 105 °F (40 °C)
  • May discolor certain fabrics and wood surfaces.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin, Fragrance, Organic Aloe Barbadensis Leaf Juice, FD&C Yellow 6, FD&C Red 40, FD&C Blue 1.

Questions?

OTC - QUESTIONS SECTION

Call Toll Free: 1-877-994-3666

SPL UNCLASSIFIED SECTION

Distributed by Genomma Lab USA, Inc. Houston, TX, 77027.

PRINCIPAL DISPLAY PANEL - 38 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ellipse™
Hand Sanitizer

Coconut Scent

1.28 fl oz
(38 mL)

PRINCIPAL DISPLAY PANEL - 38 mL Bottle Carton
PRINCIPAL DISPLAY PANEL - 38 mL Bottle Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50066-612-022025-02-01C16284748780-12cef2736-9e2e-d83d-e063-dadaa90ab31fEllipse™ Hand Sanitizer Coconut Scent

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50066-61250066-612-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
GlycerinPDC6A3C0OXIACT
Water059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
FD&C RED NO. 40WZB9127XOAIACT
FD&C BLUE NO. 1H3R47K3TBDIACT

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
e2227998-5183-48af-a718-e96a8601b987c22a7bbd-bd41-4ef4-ae58-0b0279b2f3dc2025-01-31WarningsExact identifier
spl set id: c22a7bbd-bd41-4ef4-ae58-0b0279b2f3dc

Reported adverse events (FAERS/openFDA)#

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