Otc - Active Ingredient
Active ingredients
Benzocaine 20%
Dentek Instant Pain Relief
FDA Label NDC 60630-077
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dentek Oral Care, Inc. for the product Dentek Instant Pain Relief (NDC 60630-077). 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, otc - when using, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Oral Pain Reliever
Indications & Usage
Use for the temporary relief of pain due to: . toothaches . canker sore . cold sores . sore gums
Warnings
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.
Otc - When Using
When using this product . avoid contact with the eyes . do not exceed recommended dosage . do not use for more than 7 days unless directed by a doctor/dentist
Otc - Stop Use
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
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Dosage & Administration
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 Safety Information
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 Ingredient
Inactive ingredients: Carbowax 400, Peppermint Oil, Spearmint Oil, Sucralose
Otc - Questions
Questions or comments? Call us 800-4DENTEK (433-6835) M-F 8am - 5pm EST or email us at [email protected]
* Please review the disclaimer below.
