Friday 2 September 2016

BeeGentle Gel




Generic Name: benzocaine

Dosage Form: gel
Product Information BeeGentle™ 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 and is honey flavored.

  • Not for use on patients with known sensitivity or allergies to benzocaine or other similar “caine” substances.

  • Not for use in pulpectomy procedures or application to exposed roots.

  • Ensure the material has had time for the solvent to evaporate and profound anesthesia has occurred.

  • For topical use only. Do not inject.


  • 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


  1. Twist on ViscoTip™ brush tip for easy application.

  2. Apply a generous coat of varnish to the treatment site.

  3. Wait 2 minutes after application before administering any injections or proceeding with the procedure.

  4. BeeGentle™ will release benzocaine for 20-30 minutes.

  5. Remove with wet gauze or allow saliva to dissolve.



NOTES:
  • If the material needs to be removed from the application site, use a dry cotton pellet or swab to work the material free.

  • To reduce the amount of anesthesia, use a dry brush, cotton pellet or swab to thin out the layer of varnish or work the material free.


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-CAI001C.1/22SEP2010



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 2) packs of 25 ViscoTips™

See package insert for dosage information.

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 #

006-00094


STORAGE: [32°F/0°C to 100°F/38°C]


TO REORDER:

Henry Schein

1.800.372.4346


EXPIRATION DATE: [lot and date label]


[BARCODE #: 872320000745]


PAK-CT0001C.1/22SEP2010



BACK PANEL OF REFILL 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: 20) 3cc preloaded syringes 2) packs of 25 ViscoTips™

See package insert for dosage information.

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 #

006-00095


STORAGE: [32°F/0°C to 100°F/38°C]


TO REORDER:

Henry Schein

1.800.372.4346


EXPIRATION DATE: [lot and date label]


[BARCODE #: 872320000752]


PAK-CT0002C.1/22SEP2010



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.

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: [32°F/0°C to 100°F/38°C]


NET QTY: 30mL

TO REORDER:

Henry Schein

1.800.372.4346


EXPIRATION DATE: [lot and date label]


[BARCODE #: 872320000769]


PAK-CT0003D.1/22SEP2010



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





SIDE PANEL OF REFILL KIT OUTER PACKAGING


BeeGentle


Honey Flavored Topical Anesthetic


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


NDC# 1406000204



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



BeeGentle


Honey Flavored Topical Anesthetic


Introductory Kit


Rapid, Easy Topical Anesthesia You Can See.


Net Qty: 3) 3cc prefilled syringes


Active Ingredient: Benzocaine, 20%




BeeGentle


Honey Flavored Topical Anesthetic


Refill Kit


Rapid, Easy Topical Anesthesia You Can See.


Net Qty: 20) 3cc prefilled syringes


Active Ingredient: Benzocaine, 20%




BeeGentle


Honey Flavored Topical Anesthetic


Bulk Kit


Rapid, Easy Topical Anesthesia You Can See.


Net Qty: 30mL


Active Ingredient: Benzocaine, 20%










BEEGENTLE  TOPICAL ANESTHETIC
benzocaine  gel










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)14060-002
Route of AdministrationTOPICALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzocaine (Benzocaine)Benzocaine210 mg  in 1 g








Inactive Ingredients
Ingredient NameStrength
Water 
Alcohol 


















Product Characteristics
Color    Score    
ShapeSize
FlavorHONEY (Honey Flavor (artificial))Imprint Code
Contains      






























Packaging
#NDCPackage DescriptionMultilevel Packaging
114060-002-033 SYRINGE In 1 KITcontains a SYRINGE, PLASTIC
13 g In 1 SYRINGE, PLASTICThis package is contained within the KIT (14060-002-03)
214060-002-0420 SYRINGE In 1 KITcontains a SYRINGE, PLASTIC
23 g In 1 SYRINGE, PLASTICThis package is contained within the KIT (14060-002-04)
314060-002-021 BOTTLE In 1 PACKAGEcontains a BOTTLE, PLASTIC
330 g In 1 BOTTLE, PLASTICThis package is contained within the PACKAGE (14060-002-02)










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/01/2010


Labeler - CAO Group, Inc. (102422578)

Registrant - CAO Group, Inc. (102422578)
Revised: 10/2010CAO Group, Inc.




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