PRECAINE- topical anesthetic gel gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987), DIBUCAINE (UNII: L6JW2TJG99) (DIBUCAINE - UNII:L6JW2TJG99)

Available from:

Pascal Company, Inc.

Administration route:

BUCCAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Precaine is contraindicated in patients with known hypersensitivity to amine or quinoline type anesthetics.

Authorization status:

Export only

Summary of Product characteristics

PRECAINE- TOPICAL ANESTHETIC GEL GEL
PASCAL COMPANY, INC.
----------
PRECAINE ANESTHETIC GEL
Contains: Lidocaine 8%, Dibucaine 0.8%
in a flavored aqueous base.
Net Contents 30g
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
permits maximum penetration.
Not more than one ounce (28g) per patient should be applied during a
24 hour
period.
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.
Precaine is contraindicated in patients with known hypersensitivity to
amine or quinoline
type anesthetics.
For product MSDS information please go to www.pascaldental.com or
contact Pascal
directly.
Precaine
Topical Anesthetic Gel for oral use
Strawberry
PRECAINE
topical anesthetic gel gel
PRODUCT INFORMATION
Pascal Company, Inc.
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:10866-0062
ROUTE OF ADMINISTRATION
BUCCAL, TOPICAL, DENTAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)
LIDOCAINE
80 mg in 1 g
DIBUCAINE (UNII: L6JW2TJG99) (DIBUCAINE - UNII:L6JW2TJG99)
DIBUCAINE
8 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-
0062-1
30 g in 1 JAR; Type 0: Not a Combination
Product
08/01/2000
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
Export only
08/01/2000
LABELER -
Pascal Company, Inc. (009260217)
REGISTRANT -
Alexia Petropoulos (009260217)
ESTABLISHMENT
NAME
ADDRESS
ID/FEI
BUSINESS OPERATIONS
Pascal Company, Inc.
009260217
manufacture(10866-0062)
Revised: 12/2022