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BeeGentle Gel

Generic Name: benzocaine
Dosage Form: gel

Medically reviewed on Jun 1, 2018

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA.

For further information about unapproved drugs, click here.

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.

  • 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.
  • 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. 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. BeeGentle™ will release benzocaine for 20-30 minutes.
  5. Remove with wet cotton gauze or allow saliva to dissolve

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

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) ViscoTips™
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

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

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 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

Bulk Kit

Rapid, Easy Topical Anesthesia You Can See.

Net Qty: 30mL

Active Ingredient: Benzocaine, 20%

BEEGENTLE  TOPICAL ANESTHETIC
benzocaine gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:14060-002
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOCAINE (BENZOCAINE) BENZOCAINE 210 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
Water 50 mg  in 1 g
Alcohol 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
1 NDC:14060-002-03 3 SYRINGE, PLASTIC in 1 KIT
1 3 g in 1 SYRINGE, PLASTIC
2 NDC:14060-002-04 20 SYRINGE, PLASTIC in 1 KIT
2 3 g in 1 SYRINGE, PLASTIC
3 NDC:14060-002-02 1 BOTTLE, PLASTIC in 1 PACKAGE
3 30 g in 1 BOTTLE, PLASTIC
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)
 
CAO Group, Inc.
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