Otc - Purpose
| Active Ingredient | Purpose |
| Benzocaine 10%........................................................ | Oral pain reliever |
Tanac Oral Pain Reliever Liquid
FDA Label NDC 69626-0049
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Leosons Overseas Corp for the product Tanac Oral Pain Reliever (NDC 69626-0049). 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 - purpose, uses, warnings, stop use and ask a doctor or dentist if, if pregnant or breast-feeding,, do not use, when using this product, 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
Uses
Temporarily relieves pain due to
- canker sores
- cold sores
- fever blisters
- minor irritations or injury of the mouth and gums
Warnings
For oral use only.
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. If a skin reaction occurs, stop use
and seek medical help right away.
Flammability warning: Keep away from fire or flame.
Stop Use And Ask A Doctor Or Dentist If
- sore mouth symptoms do not improve in 7 days
- symptoms clear up and occur again within a few days
- irritation, pain or redness persists or worsens swelling, rash, or fever develops
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Do Not Use
- for teething
- in children under 2 years of age
When Using This Product
- avoid contact with the eyes
- do not use more than directed
- do not use for more than 7 days unless directed by a dentist or doctor
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- apply product with cotton swab or clean fingertip to the affected area
- adults and children 2 years of age and older: use up times 4 times daily or as directed by a
- children under 2 years of age: do not use
dentist or doctor. Children should be supervised in the use of this product.
Other Information
- store at 20 - 25°C (68 - 77°F)
- do not use if imprinted safety seal is torn, broken or missing prior to opening
- keep carton for full drug facts
Inactive Ingredients
benzalkonium chloride, peppermint oil, polyethylene glycol 400, propylene glycol, sodium saccharin, tannic acid
Questions?
1-855-452-9500 or email at [email protected]
Principal Display Panel
- canker sores
- gum irritations
- cold sores
- fever blisters
Tanac ®
Benzocaine 10%
Oral Pain Reliever
NO STING LIQUID
0.45 FL Oz. (13.3mL)
* Please review the disclaimer below.
