EASY GEL- sterile lubricating jelly gel

Easy Gel by

Drug Labeling and Warnings

Easy Gel by is a Other medication manufactured, distributed, or labeled by Leosons Overseas Corp, Ultra Seal Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Use

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

Directions

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

Warnings

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

Other Information

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

EASYGEL™

STERILE

LUBRICATING JELLY

Water Soluble Bacteriostatic

NET WT. 4 OZ (113.4 G)

INGREDIENTS AND APPEARANCE

EASY GEL 
jelly, lubricating, for transurethral surgical instrument gel

Product Information
Product Type	MEDICAL DEVICE	Item Code (Source)	NHRIC:69626-0011
Route of Administration	RECTAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	Water (UNII: 059QF0KO0R)
INGR	Glycerin (UNII: PDC6A3C0OX)
INGR	Carboxypolymethylene (UNII: 0A5MM307FC)
INGR	Carboxymethylcellulose Sodium, Unspecified Form (UNII: K679OBS311)
INGR	Methylparaben (UNII: A2I8C7HI9T)
INGR	Edetate Disodium Anhydrous (UNII: 8NLQ36F6MM)
INGR	Sodium Hydroxide (UNII: 55X04QC32I)
INGR	Propylparaben (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:69626-0011-5	113.4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Exempt device	FHX	12/01/2016

Labeler - Leosons Overseas Corp (148605470)

Establishment
Name	Address	ID/FEI	Business Operations
Ultra Seal Corporation		085752004	MANUFACTURE