The following Structured Product Label (SPL) was submitted to the FDA by Pascal Company, Inc. for the product Precaine B Bubblegum (NDC 10866-0088). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding directions, warnings, contraindications, other information, precaine b, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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
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.
Precaine B is contraindicated in patients with known hypersensitivity to benzocaine or PABA.
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
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
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