Otc - Active Ingredient
Benzocaine 200mg (in each g)
Patterson Dental Topical Anesthetic Gel
FDA Label NDC 50227-1012
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Patterson Dental for the product Patterson Dental Topical Anesthetic (NDC 50227-1012). 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, indications & usage, warnings, dosage & administration, otc - keep out of reach of children, storage and handling, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Oral Anesthetic
Indications & Usage
For oral mucosal use only, as directed by dentist. For the temporary relief of pain due to minor dental procedures.
Warnings
Methemoglobinemia warning: Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of o 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
- for more than 7 days unless directed by a physician. If sore mouth symptoms do not improve in 7 days; irritation, pain, or redness persists or worsens; or if swelling, rash or fever develops, see your physician promptly.
- for teething
- in children under 2 years of age
Allergy Alert: Do not use on patients with a history of allergies to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.
Do not use
When using this product Avoid contact with eyes. If contact occurs, flush with water.
Do not exceed recommended dosage. If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away.
If pregnant or breast feeding, ask a physician before use.
Dosage & Administration
- Apply only amount needed to the oral mucosa to prevent or relieve pain.
- children under 2 years of age: do not use
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Storage And Handling
Store at 59°-86°F (15°-30°C). Protect from freezing.
Inactive Ingredient
flavoring, PEG 3350, PEG 400, sodium saccharin. May contain blue #1, green #3, green #5, red #3, red #28, red #40, yellow #5, (tartrazine), yellow #6, as a color additive.
Otc - Questions
800.873.7683
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