Drugs Facts
Active Ingredients Purpose
Benzocaine 20% Anesthetic
Benz O Sthetic
FDA Label NDC 54162-926
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Geritrex Llc for the product Benz O Sthetic (NDC 54162-926). 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 drugs facts, uses, directions, dosage & administration, warnings, other ingredients, storage, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
For temporary relief of oral pain associated with: · toothache ·canker sores ·minor dental
procedures · minor injury of the mouth and gum caused by dentures or orthodontic appliances.
Directions
Apply with cotton applicator or finger tip to affected gum area
up to 4 times a day or as directed by your dentist.
Dosage & Administration
Do not use for more thatn 7 days.
Warnings
Do not use this product if you have a history of allergy to
local anesthetic such as Procaine, Benzocaine or other
“Caines”. Not recommended for children under the age of 2.
Other Ingredients
Benzyl Alcohol, Cherry Flavor, FD&C Red #40, PEG 3350, PEG 400, Sodium Saccharin
Storage
Store at controlled room temperature 20-25°C (68-77°F).
Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN
Package Label.Principal Display Panel
Image Description (Begt15)
Image Description (Begb29 Page 001)
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