Active Ingredient
Benzocaine 20%
Dentek Instant Pain Relief
FDA Label NDC 83062-410
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Iimed Medical Mexicana S. De R.l. De C.v for the product Dentek Instant Pain Relief (NDC 83062-410). 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 active ingredient, purpose, uses, warnings, when using this product, stop use and ask a dentist or doctor if, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Oral Pain Reliever
Uses
for the temporary relief of pain due to:
- toothaches
- canker sore
- cold sores
- sore gums
Warnings
Allergy Alert: do not use this product if you have a history of allery to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.
When Using This Product
- avoid contact with the eyes
- do not exceed recommended dosage
- do not use for more than 7 days unless than directed by a doctor/dentist
Stop Use And Ask A Dentist Or Doctor If
- swelling, rash or fever develops
- irritation, pain or redness persists or worsens
- symptoms do not improve in 7 days
Keep Out Of Reach Of Children
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
dip applicator into liquid
Adults and children 2 years of age and older: Apply a small amount of product 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: Ask a dentist or doctor.
Other Information
- do not use if safety seal on carton is broken
- this preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist can be consulted
- do not use continuously
Inactive Ingredients
Carbowax 400, Peppermint Oil, Spearmint Oil, Sucralose
Questions Or Comments?
Call us 800-4DENTEK (433-6835) M-F 8am - 5pm EST or email us at [email protected]
Dentek Instant Pain Relief Inner Vial Label
Entire Label (67659 410 04)
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