Oral Pain Relief
Oral Pain Relief is an FDA drug label for the active ingredient BENZOCAINE manufactured by GERI-CARE PHARMACEUTICAL CORP administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20231031.
Generic: BENZOCAINE
Manufacturer: GERI-CARE PHARMACEUTICAL CORP
Product Type: HUMAN OTC DRUG
Route: ORAL
Dosage Form:
NDC: 57896-139
Application: M022
Effective: 20231031
Active Ingredients: Active Ingredient Benzocaine 20%
Indications & Usage
Uses temporary relieves pain associated with the following mouth and gum irritations: • toothache • sore gums • canker sores • braces • minor dental procedures • dentures
Dosage & Administration
Directions • do not exceed recommended dosage • do not use for more than 7 days unless told to do so by a dentist or doctor • adults and children 2 years of age or older: apply to affected area up to 4 times daily or as directed by doctor/dentist • children between 2 and 12 years of age: adult supervision should be given in use of this product • children under 2 years of age: do not use
Contraindications
Not available.
Warnings
Warnings METHEMOGLOBINEMIA WARNING: Use of this product may cause methemoglobinemia, a 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 this product 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 Allergy alert: Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics. If a skin reaction occurs, stop use and seek medical help right away. Do not use • for teething • in children under 2 years of age • more than recommended • for more than 7 days unless told to do so by a dentist or doctor When using this product • avoid contact with the eyes Stop use and ask a doctor if • sore mouth symptoms do not improve in 7 days • irritation, pain, or redness persists or worsens • swelling, rash or fever develops Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Adverse Reactions
Not available.