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Precaine B Gel

Generic Name: benzocaine
Dosage Form: topical anesthetic gel

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.

Directions

Application Directions:

For topical use only

For best results apply to previously dried oral mucosa with cotton swab or similar applicator for adquate control of pain

Removal of excess saliva during application minimizes dilution of the anesthetic and permits maximum penetration

Not more than 1.2mg per Kg body weight per patient should be applied during a 24-hour period

Warnings

Warning:

Recommended dosage should not be exceeded due to possible side effects.

Keep out of the reach of children.

For professional use only.

Do not use in the eyes.

Avoid swallowing.

Not for home or unsupervised consumer use.

Not for use on children 2 and younger or pregnant or nursing women.

Contraindications

Precaine B is contraindicated in patients with known hypersensitivity to benzocaine or PABA.

Other Information

For product SDS information, please got to www.pascaldental.com or contact Pascal directly.

Store product between 60 degrees F (16 degrees C) and 86 degrees F (30 degrees C)

Rx only in USA

Made in USA

Precaine B

Precaine B

Topical Anesthetic Gel for oral us

Bubblegum

Contains: Benzocaine 20% in a flavored aqueous bse

Net Contents: 30g

Pascal International

2929 NE Northup Way

Bellevue, WA 98004

425.827.4694

REF 15-350

SN72506/1115

PRECAINE B BUBBLEGUM 
benzocaine topical anesthetic gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:10866-0088
Route of Administration DENTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOCAINE (BENZOCAINE) BENZOCAINE 221 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
CARBOMER 934 125 mg  in 1 g
Product Characteristics
Color red Score     
Shape Size
Flavor BUBBLE GUM Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:10866-0088-1 30 g in 1 JAR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 01/27/2016
Labeler - Pascal Company, Inc. (009260217)
Establishment
Name Address ID/FEI Operations
Pascal Company, Inc. 009260217 manufacture(10866-0088)
Revised: 08/2016
 
Pascal Company, Inc.



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