FDA Label for Precaine B Chocolate Mint
View Indications, Usage & Precautions
Precaine B Chocolate Mint Product Label
The following document was submitted to the FDA by the labeler of this product Pascal Company, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Directions:
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 1.2 mg 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 eye.
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 go 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 is USA
Made in USA
Precaine B
Precaine B
Topical Anesthetic Gel for Oral Use
Chocolate Mint
Contains: Benzocaine 20% in a flavored aqueous base
Net Contents: 30g
Pascal International
2929 Northup Way
Bellevue, WA 98004
425-827-4694
REF 15-350
SN72507/0217
* Please review the disclaimer below.
