Label: PRECAINE B BUBBLEGUM- benzocaine topical anesthetic gel
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Contains inactivated NDC Code(s)
NDC Code(s): 10866-0088-1 - Packager: Pascal Company, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
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Drug Label Information
Updated January 22, 2020
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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
- Contraindications
- Other Information
- Precaine B
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INGREDIENTS AND APPEARANCE
PRECAINE B BUBBLEGUM
benzocaine topical anesthetic gelProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10866-0088 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 Inactive Ingredients Ingredient Name Strength CARBOMER 934 (UNII: Z135WT9208) 125 mg in 1 g Product Characteristics Color red Score Shape Size Flavor BUBBLE GUM Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10866-0088-1 30 g in 1 JAR; Type 0: Not a Combination Product 01/27/2016 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 Business Operations Pascal Company, Inc. 009260217 manufacture(10866-0088)