EASY GEL (STERILE LUBRICATING JELLY) GEL [LEOSONS OVERSEAS CORP]

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  • EASY GEL (STERILE LUBRICATING JELLY) GEL [LEOSONS OVERSEAS CORP]

EASY GEL (STERILE LUBRICATING JELLY) GEL [LEOSONS OVERSEAS CORP]
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NDC 69626-0011-5
Set ID 2a9a3aba-d3e0-4fd2-a3f7-535d25fba4eb
Category MEDICAL DEVICE
Packager Leosons Overseas Corp
Generic Name
Product Class
Product Number
Application Number FHX
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  • 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

    EASY•GEL™

    STERILE

    LUBRICATING JELLY

    Water Soluble • Bacteriostatic

    NET WT. 4 OZ (113.4 G)

    PRINCIPAL DISPLAY PANEL - 113.4 G Tube Box
  • INGREDIENTS AND APPEARANCE
    EASY GEL 
    jelly, lubricating, for transurethral surgical instrument gel
    Product Information
    Product TypeMEDICAL DEVICEItem Code (Source)NHRIC:69626-0011
    Route of AdministrationRECTAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWater (UNII: 059QF0KO0R)  
    INGRGlycerin (UNII: PDC6A3C0OX)  
    INGRCarboxypolymethylene (UNII: 0A5MM307FC)  
    INGRCarboxymethylcellulose Sodium, Unspecified Form (UNII: K679OBS311)  
    INGRMethylparaben (UNII: A2I8C7HI9T)  
    INGREdetate Disodium Anhydrous (UNII: 8NLQ36F6MM)  
    INGRSodium Hydroxide (UNII: 55X04QC32I)  
    INGRPropylparaben (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:69626-0011-5113.4 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Exempt deviceFHX12/01/2016
    Labeler - Leosons Overseas Corp (148605470)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ultra Seal Corporation085752004MANUFACTURE
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