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Drug Facts
DISTRIBUTED BY TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60057
QUESTIONS" 1-888-423-0139
[email protected] www.topcarebrand.com
Topcare Oral Pain Relief Gel
FDA Label NDC 36800-512
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Topcare Oral Pain Relief (NDC 36800-512). 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 other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active ingredient
Benzocaine 20%
Otc - Purpose
Purpose
Oral Pain Reliever
Indications & Usage
Use
- for the temporary relief of pain due to toothaches
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
Otc - Do Not Use
Do not use
- more than directed
- for more than 7 days unless told to do so by a dentist or doctor
- for teething
- in children under 2 years of age
Otc - Stop Use
Stop use and ask a doctor if
- swelling, rash, fever develops
- irritation, pain or redness persists or worsens
- symptoms do not improve in 7 days
- allergic reaction occurs
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
- cut open tip of tube on scoremark
- adults and children 2 years of age and older: apply a small amount of product to the cavity and around the the gum surrounding the teeth. 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: do not use
Other Safety Information
Other information
- do not use if tip is cut prior to opening
- this preparation is intended for use in cases of toothache, only as a tempory expedient until a dentist can be consulted
- do not use continuously
Inactive Ingredient
Inactive ingredients flavor, polyethylene glycol, sodium saccharin, sorbic acid
Package Label.Principal Display Panel
TopCare® health™
MAXIMUM STRENGTH
Oral Pain Relief Gel
BENZOCAINE 20%
NET WT 0.5 OZ (14 g)
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