7T LIDO (LIDOCAINE HYDROCHLORIDE AND BENZETHONIUM CHLORIDE) GEL [7T PHARMA LLC]

7T LIDO (LIDOCAINE HYDROCHLORIDE AND BENZETHONIUM CHLORIDE) GEL [7T PHARMA LLC]
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NDC 70645-804-26
Set ID 6cf2e7af-9ede-4b47-a6b5-b88ecb8b423f
Category MEDICAL DEVICE
Packager 7T Pharma LLC
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number K020540
  • SPL UNCLASSIFIED SECTION

    --------------------
    7T LIDO GEL
    Rx Only
    For external use only
    Not for ophthalmic use

  • 7T LIDO GEL Description

    7T LIDO GEL is a soothing viscous hydrogel wound dressing containing lidocaine 2% as a topical anesthetic intended for use in the local management of painful skin wounds. 7T LIDO GEL also helps to relieve dry, waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.
    7T LIDO GEL contains: Lidocaine HCl, Benzethonium Chloride, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Glycerin, Hydrolyzed Collagen, Hydroxyethylcellulose, Sodium Alginate, Tocopheryl Acetate (Vitamin E), Triethanolamine.

  • INDICATIONS AND USES

    7T LIDO GEL is intended to be used under the supervision of a healthcare professional to be used as local management of skin wounds, including pressure ulcers, venous stasis ulcers, first and second degree burns, and superficial wounds and scrapes.

  • WARNINGS

    For external use only. Do not use this product if you are allergic to any of the ingredients listed. Avoid contact with eyes. Sterile unless opened or damaged. If this product is applied properly and skin irritation still occurs, discontinue use and consult your physician. If ingested, get medical help or contact Poison Control Center right away.

    KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.

    This medication should be used as directed by your physician during pregnancy or while breastfeeding. Consult your doctor about the risks and benefits.

    CAUTION: Federal law restricts this device to sale by or on the order of a physician

  • ADVERSE REACTIONS

    On rare occasions, the gel may cause temporary redness, stinging, burning or irritation and normally disappear when the medication is discontinued.

  • How is 7T LIDO GEL Supplied

    7T LIDO GEL is supplied as a gel in:
    3 oz. (85g) tube
    NDC: 70645-804-26

    Store at 20°-25°C (68° to 77°F); Keep away from heat and protect from freezing. [See USP Controlled Room Temperature.]

  • SPL UNCLASSIFIED SECTION

    Manufactured for:
    7T Pharma, LLC
    Los Angeles, CA 90064

  • PRINCIPAL DISPLAY PANEL

    7T Lido Gel

    Rx ONLY

    NDC 70645-804-26

    3oz (85g)

    7T Lido Gel Rx ONLY NDC 70645-804-26 3oz (85g)


  • INGREDIENTS AND APPEARANCE
    7T LIDO 
    dressing, wound and burn, hydrogel w/drug and/or biologic gel
    Product Information
    Product TypeMEDICAL DEVICEItem Code (Source)NHRIC:70645-804
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS2 mg  in 100 mg
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE0.5 mg  in 100 mg
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MARINE COLLAGEN, SOLUBLE (UNII: 8JC99XGU4W)  
    HYDROXYETHYL CELLULOSE (1500 MPA.S AT 1%) (UNII: L605B5892V)  
    SODIUM ALGINATE (UNII: C269C4G2ZQ)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:70645-804-2685000 mg in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    PREMARKET NOTIFICATIONK02054008/01/2018
    Labeler - 7T Pharma LLC (080220022)

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