Otc - Active Ingredient
Benzocaine 20%
Purpose Oral pain reliever
Fgper Oral Pain Relief Spray
FDA Label NDC 85593-160
7 label sections · Submitted to the FDA by Guangzhou Chuanma International Trading Co.,ltd. · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Chuanma International Trading Co.,ltd. for the product Fgper Oral Pain Relief (NDC 85593-160). 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 - keep out of reach of children, otc - purpose, warnings, indications & usage, dosage & administration, inactive ingredient, 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 - Keep Out Of Reach Of Children
Keep out of reach of children.If more than used for painis accidentallyswallowed, get medical help or contact a PoisonControl Center right away.
Otc - Purpose
Temporarily relieves pain associated with thefollowing mouth and gum irritations:ollen nasalmembranes so you can·Toothache.Sore gums-Canker sores
Warnings
Warnings:
Methemoglobinemia warningUse of benzocaine may causemethemoglobinemia, a rare but serious
condition that must be treated promptly because
It reduces the amount of oxygen carried in blood.
This can occur even if you have used benzocaine
before. Stop use and seek immediate medical
attention if you or a child in your care develops:
.Pale, gray, or blue colored skin (cyanosis)
·Headache
Rapid heart rate
Shortness of breath
·Dizziness or lightheadedness
Fatigue or lack of energy
Indications & Usage
Do not use benzocaine ifyou have a history ofallergy to local anesthetics such as procaine,butacaine, benzocaine, or other "caine"anesthetics.
Do not use
· For teething In children under 2 years of age
Stop use and ask a doctor if·Swelling, rash, or fever develops
.Sore mouth symptoms do not improve in 7 days
-Irritation, pain, or redness persists or worsens
Dosage & Administration
When using this product
· Avoid contact with the eyesby a dentist or doctor
Do not exceed recommended dosage
Do not use for more than 7 days unless directed
Inactive Ingredient
benzalkonium chloride, benzocaine, CopperTripeptide-1,glycerin, methylparaben, purified water
* Please review the disclaimer below.
