Otc - Active Ingredient
Benzocaine 10%
Purpose:Oral Pain Reliever
Toothache Relief Spray
FDA Label NDC 87083-021
7 label sections · Submitted to the FDA by Guchutang Biotechnology (longyan) Co., Ltd · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guchutang Biotechnology (longyan) Co., Ltd for the product Toothache Relief (NDC 87083-021). 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 otc - active ingredient, otc - purpose, otc - keep out of reach of children, warnings, dosage & administration, inactive ingredient, indications & usage, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Oral pain reliever
Uses
temporarily relieves pain due to toothache
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
Warnings
For external use only. Do not use in large quantities, particularly over raw surfaces or blistered areas.
Dosage & Administration
temporarily relieves pain due to toothache Adults: spray directly into mouth and allow to remain in place. Do not swallow. Use up to 4 times daily.
Inactive Ingredient
Propyene Glycol, Glycerin Ethanol CitricAdid, Mint, SodiumSaccharin,Disodium EDTA,Ceylpyridinium Chboride, Water,Pclysorbate.
Indications & Usage
Do not use in large quantities, particularly over raw surfaces or blistered areas.
* Please review the disclaimer below.
