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BeeGentle (CAO Group, Inc.)

Available Formats

Dosage Form Package Information Links
GEL 1 BOTTLE, PLASTIC in 1 PACKAGE (14060-002-02) > 30 g in 1 BOTTLE, PLASTIC Label Information
GEL 20 SYRINGE, PLASTIC in 1 KIT (14060-002-04) > 3 g in 1 SYRINGE, PLASTIC Label Information
GEL 3 SYRINGE, PLASTIC in 1 KIT (14060-002-03) > 3 g in 1 SYRINGE, PLASTIC Label Information

Complete BeeGentle Information

  • DESCRIPTION

    BeeGentleâ„¢ is a water-insoluble topical anesthetic containing 20% benzocaine which forms an insoluble film upon contact with moist tissue. The film releases benzocaine at a constant rate over a 20-30 minute period. The anesthetic adheres to soft tissue forming a white film that remains in place until physically removed or until slowly dissolved by saliva. This unique time-release benzocaine anesthetic provides longer lasting anesthesia versus conventional water-soluble products. BeeGentle has an ethanol based solvent.


  • CONTRAINDICATIONS

    • Avoid contact with eyes. If this happens, rinse thoroughly with water.
    • Not for pulpectomy procedures or application to exposed roots.
    • For topical use only. DO NOT INJECT
    • Do not eat for one hour following use.
    • Do not chew gum or food while numbness persists.
    • Hypersensitivity/allergy has been known to occur, in which case discontinue use.
    • Not for treatment of teething.
    • Not for use in children under 2 years of age.
    • Avoid thick coatings, or allowing the gel to solidify as a thick layer.
    • Do not use beyond expiration date.

  • STORAGE AND HANDLING

    • Do not store above 100°F (38°C). Do not freeze. Do not use beyond indicated shelf life.
    • Do not use if the packaging has been damaged or if the seals are found to be broken or open.
    • Shelf Life: 2 years

  • DOSAGE & ADMINISTRATION

    1. Twist on ViscoTipâ„¢ brush tip for easy application.
    2. Prior to Injection. Apply a moderate coat of varnish to the moist tissue. Once applied, spread out to a thin layer. Prior to scaling/root planning. Apply a moderate coat of varnish to the moist tissue. Once applied, spread out to a thin layer.
    3. Allow saliva to contact varnish in order to solidify the varnish into a white layer, profound anesthesia is achieved in about 2 minutes.
    4. BeeGentleâ„¢ will release benzocaine for 20-30 minutes.
    5. Remove with wet cotton gauze or allow saliva to dissolve

  • WARNINGS AND PRECAUTIONS

    Methemoglobinemia warning:
    Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in the blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if the patient develops:

    • pale, gray, or blue colored skin (cyanosis)
    • headache
    • rapid heart rate
    • shortness of breath
    • dizziness or lightheadedness
    • fatigue or lack of energy

    Flammability warning:
    Flammable: Avoid open flames or sources of ignition. Do not store above indicated temperatures.

    Back page of Complete Instructions:

    Caution: Federal law restricts this device to sale by or on the order of a licensed professional.

    Disclaimer: CAO Group believes this information to be accurate and is offered only for the benefit of its customers for use of the product under proscribed conditions. This document is not to be considered a warranty or guarantee of product performance, and CAO Group is not legally bound to such claims based on this document.

    Manufactured by CAO (China) Medical Equipment Co,. Ltd. for CAO Group. Inc.

    P 877.236.4408 F 801.256.9287
    4628 West Skyhawk Drive, West Jordan, UT 84084-4501 U.S.A.
    www.caogroup.com

    SAL-CAI001 REV7 30MAY2018


  • DESCRIPTION

    BACK PANEL OF INTRO KIT OUTER PACKAGING

    Manufactured by CAO (China) Medical Equipment Co., Ltd. for CAO Group, Inc.

    4628 West Skyhawk Drive
    West Jordan, UT 84084
    U.S.A.
    877-236-4408 (tel)
    801-256-9287 (fax)
    www.caogroup.com

    PACKAGE CONTENTS: 3) 3cc preloaded syringes, 50) ViscoTipsâ„¢
    See package insert for dosage information, contraindications, and precautions. CAUTION: Methemoglobinemia risk, see package insert.
    Rx Only. Dispose of properly after use. For complete safety information see product MSDS.
    Do not use if the packaging has been damaged, or if the safety seals are broken.

    REORDER #
    006-00094

    STORAGE: [40°F/5°C to 100°F/38°C]

    EXPIRATION DATE: [lot and date label]

    [BARCODE #: 872320000745]

    PAK-CT0001 v. 10.15.01


  • DESCRIPTION

    BACK PANEL OF BULK KIT OUTER PACKAGING

    Manufactured by CAO (China) Medical Equipment Co., Ltd. for CAO Group, Inc.

    4628 West Skyhawk Drive
    West Jordan, UT 84084
    U.S.A.
    877-236-4408 (tel)
    801-256-9287 (fax)
    www.caogroup.com

    See package insert for dosage information, contraindications, and precautions

    CAUTION: Methemoglobinemia risk, see package insert. Rx Only. Dispose of properly after use. For complete safety information see product MSDS.
    Do not use if the packaging has been damaged, or if the safety seals are found to be broken.

    REORDER #
    006-00096

    STORAGE: [40°F/5°C to 100°F/38°C]

    NET QTY: 30mL

    EXPIRATION DATE: [lot and date label]

    [BARCODE #: 872320000769]

    PAK-CT0003 v. 06.16.01


  • DESCRIPTION

    SIDE PANEL OF INTRO KIT OUTER PACKAGING

    BeeGentle

    Honey Flavored Topical Anesthetic

    Ingredients: Ethyl alcohol, benzocaine, proprietary polymer thickener, water/eau, honey flavor, sucralose

    NDC# 1406000203



  • DESCRIPTION

    SIDE PANEL OF BULK KIT OUTER PACKAGING

    BeeGentle

    Honey Flavored Topical Anesthetic

    Ingredients: Ethyl alcohol, benzocaine, proprietary polymer thickener, water/eau, honey flavor, sucralose

    NDC# 1406000202


  • PRINCIPAL DISPLAY PANEL

    BeeGentle

    Honey Flavored Topical Anesthetic

    Introductory Kit

    Rapid, Easy Topical Anesthesia You Can See.

    Net Qty: 3) 3cc prefilled syringes

    Active Ingredient: Benzocaine, 20%

    Intro Kit Front Panel


  • PRINCIPAL DISPLAY PANEL

    BeeGentle

    Honey Flavored Topical Anesthetic

    Bulk Kit

    Rapid, Easy Topical Anesthesia You Can See.

    Net Qty: 30mL

    Active Ingredient: Benzocaine, 20%

    Bulk Kit Front Panel


  • INGREDIENTS AND APPEARANCE
    BEEGENTLE  TOPICAL ANESTHETIC
    benzocaine gel
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:14060-002
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 210 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    Water (UNII: 059QF0KO0R) 50 mg  in 1 g
    Alcohol (UNII: 3K9958V90M) 472.5 mg  in 1 g
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor HONEY (Honey Flavor (artificial)) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:14060-002-03 3 in 1 KIT 10/07/2010
    1 3 g in 1 SYRINGE, PLASTIC; Type 0: Not a Combination Product
    2 NDC:14060-002-04 20 in 1 KIT 10/07/2010 10/07/2010
    2 3 g in 1 SYRINGE, PLASTIC; Type 0: Not a Combination Product
    3 NDC:14060-002-02 1 in 1 PACKAGE 10/07/2010
    3 30 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 09/01/2010
    Labeler - CAO Group, Inc. (102422578)
    Registrant - CAO Group, Inc. (102422578)