FDA.reportPublic FDA data

Easy Gel

Manufacturer
Leosons Overseas Corp | Ultra Seal Corporation
Effective date
2016-12-14
Label type
MEDICAL DEVICE
Version
1
Source
full-release
Hydrated at
2026-06-01 02:48:22

Label at a glance#

ProductEasy Gel
Label structure6 sections

Dosage and administration

Before first use, remove or puncture seal under cap . Squeeze lubricating jelly out of tube as needed. Discard after use.

Storage and handling

Store at room temperature: 15–30º C (59–86º F). Lot number and expiration date on crimp. Sterility of contents guaranteed unless package is opened, damaged, or the seal is not intact.

Label contents#

Full prescribing information#

Use

INDICATIONS & USAGE SECTION

For lubrication to provide easy insertion of catheters, endoscopes, or gloved fingers into bodily orifices.

Directions

DOSAGE & ADMINISTRATION SECTION

Before first use, remove or puncture seal under cap. Squeeze lubricating jelly out of tube as needed. Discard after use.

Warnings

WARNINGS SECTION

If irritation or discomfort occurs, discontinue use and consult a doctor. Keep out of reach of children. Avoid contact with eyes.

Other Information

STORAGE AND HANDLING SECTION

Store at room temperature: 15–30º C (59–86º F). Lot number and expiration date on crimp. Sterility of contents guaranteed unless package is opened, damaged, or the seal is not intact.

SPL UNCLASSIFIED SECTION

Chlorhexidine Gluconate (CHG) was not used in the manufacture of this product.

PRINCIPAL DISPLAY PANEL - 113.4 G Tube Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EASY•GEL™

STERILE

LUBRICATING JELLY

Water Soluble • Bacteriostatic

NET WT. 4 OZ (113.4 G)

PRINCIPAL DISPLAY PANEL - 113.4 G Tube Box
PRINCIPAL DISPLAY PANEL - 113.4 G Tube Box

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69626-0011-5Easy Gel113.4 g in 1 TUBEGEL113.41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69626-0011EASY GEL (STERILE LUBRICATING JELLY) GEL [LEOSONS OVERSEAS CORP]11 package rows20161229_2a9a3aba-d3e0-4fd2-a3f7-535d25fba4eb.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69626-001169626-0011-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
Water059QF0KO0RINGR
GlycerinPDC6A3C0OXINGR
Carboxypolymethylene0A5MM307FCINGR
Carboxymethylcellulose Sodium, Unspecified FormK679OBS311INGR
MethylparabenA2I8C7HI9TINGR
Edetate Disodium Anhydrous8NLQ36F6MMINGR
Sodium Hydroxide55X04QC32IINGR
PropylparabenZ8IX2SC1OHINGR

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 3 · 59 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsName fallback
generic name: WATER
NINA WATER (Rich anions,Alkaline Balancing Water)WATERDMBIO.CO.,LTD.58cbda7e-70c9-af85-e063-6394a90a0d172026-08-11WarningsName fallback
generic name: WATER
NINA WATER (Rich anions,Alkaline Balancing Water)WATERDMBIO.CO.,LTD.58b9b24c-7014-eb45-e063-6294a90ae4822026-08-10WarningsName fallback
generic name: WATER
Sterile WaterWATERCardinal Health 107, LLC48d75a7c-8329-48a8-bea0-a8c144ddf6372026-08-07Warnings, Adverse reactionsName fallback
generic name: WATER
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsName fallback
generic name: WATER
RemodulinTREPROSTINILUnited Therapeutics Corporation6c80bb38-e8db-4138-9f0d-dbbf9c6731852026-07-02Warnings, Adverse reactionsName fallback
generic name: WATER
Sterile WaterWATERHospira, Inc.3a6422e1-feee-4095-8883-2b0837039e6e2026-05-07Warnings, Adverse reactionsName fallback
generic name: WATER
NINA WATER (Rich anions)WATERBIOHERB Co., Ltd.16053e79-189e-4cdf-e063-6394a90ac7762026-04-11WarningsName fallback
generic name: WATER
Sterile WaterWATERHospira, Inc.2b9ea23a-f9e9-48a8-25b7-519e3bbd68282026-03-18Warnings, Adverse reactionsName fallback
generic name: WATER
INSULIN DILUTING MEDIUM FOR KirstyWATERBiocon Biologics Inc.3db1d482-7e1f-aec6-79ef-3f305b4d82772026-01-20Warnings, Adverse reactionsName fallback
generic name: WATER
pH Neutral Emergency EyewashWATERINNOVATIVE SAFETY SUPPLY INC.29a1bd1e-d0dd-478f-e063-6394a90ab0aa2026-01-08WarningsName fallback
generic name: WATER
Quality Choice Eye WashWATERChain Drug Marketing Assoc., Inc.1fb8a109-351b-7039-e063-6394a90a73112025-12-30WarningsName fallback
generic name: WATER
OCUFRESHWATEROptics Laboratory Inc.b8e477a9-66b9-496b-92fb-3d4bbd7b36b52025-12-29WarningsName fallback
generic name: WATER
Sterile WaterWATERProPharma Distribution386a0a2f-4ff7-f128-e063-6294a90a7d4d2025-12-18Warnings, Adverse reactionsName fallback
generic name: WATER
PUR-WASHWATERNiagara Pharmaceuticals Inc.beda35c3-9a8b-47ad-e053-2995a90a7b1b2025-11-24WarningsName fallback
generic name: WATER
Easy Care First Aid EyewashWATERTender Corporationa070aac8-e6d2-ef10-e053-2a95a90aa5b12025-11-24WarningsName fallback
generic name: WATER
PUR-WASHWATERNiagara Pharmaceuticals Inc.e07a064b-f680-405c-bbcd-24fac430951e2025-11-24WarningsName fallback
generic name: WATER
PUR-WASHWATERNiagara Pharmaceuticals Inc.777e1559-786f-8d54-e053-2991aa0aa98d2025-11-24WarningsName fallback
generic name: WATER
PUR-WASHWATERNiagara Pharmaceuticals Inc.7289103a-5cbf-42f4-8848-e827149a43ca2025-11-24WarningsName fallback
generic name: WATER
Sterile WaterWATERFresenius Kabi USA, LLCfd823bef-c14c-4708-a18a-8aaa8470412f2025-11-18Warnings, Adverse reactionsName fallback
generic name: WATER

Reported adverse events (FAERS/openFDA)#

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