Ioline
Ioline is an FDA drug label for the active ingredient BENZOCAINE manufactured by Dharma Research, Inc. administered by DENTAL. 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 20231010.
Generic: BENZOCAINE
Manufacturer: Dharma Research, Inc.
Product Type: HUMAN OTC DRUG
Route: DENTAL
Dosage Form:
NDC: 53045-137
Application: M022
Effective: 20231010
Active Ingredients: Active Ingredient Benzocaine, 20%
Indications & Usage
Uses For the temporary relief of pain associated with canker sores and minor dental procedures.
Dosage & Administration
Directions Adults and children 2 years of age and older: Apply to the affected area. Use up to 4 times daily or as directed by a dentist or doctor. Children under 12 years of age should be supervised in the use of this product Children under 2 years of age: Consult a dentist or doctor.
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 the blood. This can occur even if you have used this product before. Stop use and seek 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. Do not use this product for more than 7 days unless directed by a dentist or a doctor. If sore mouth symptoms do not improve in 7 days; if irritation, pain, or redness persists or worsens; or if swelling, rash, or fever develops, see your dentist or doctor promptly. Do not exceed recommended dosage.
Adverse Reactions
Not available.