Label: PRECAINE B- benzocaine topical anesthetic gel
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Contains inactivated NDC Code(s)
NDC Code(s): 10866-0087-1 - Packager: Pascal Company, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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.
Drug Label Information
Updated December 19, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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Directoons
Application Directions:
For topical use only
For best results apply to previously dried oral mucosa with cotton swab or similar applicator for adequate control of pain
Removal of excess saliva during application minimizes dilution of the anesthetic and perimts maximum penetration
Not more than 1.2mg per Kg body weight per patient should be applied during a 24-hour period
- Warnings
- Contraindications
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Other Information
For product MSDS information, please go to www.pascaldental.com or contact Pascal directly
Store product between 60 degress F (16 degress C) and 86 degrees F (30 degress C)
Rx only in USA
Made in USA
- Precaine B
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INGREDIENTS AND APPEARANCE
PRECAINE B
benzocaine topical anesthetic gelProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10866-0087 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 221 mg in 1 g Product Characteristics Color red Score Shape Size Flavor STRAWBERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10866-0087-1 30 g in 1 JAR; Type 0: Not a Combination Product 04/27/2009 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 04/27/2009 Labeler - Pascal Company, Inc. (009260217) Establishment Name Address ID/FEI Business Operations Pascal Company, Inc. 009260217 manufacture(10866-0087)
