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Drug Facts
Kanka Triple Action Gel
FDA Label NDC 10157-2127
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Blistex Inc. for the product Kanka Triple Action (NDC 10157-2127). 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 - purpose, uses, methemoglobinemia warning, allergy alert, do not use, when using this product, 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 - Purpose
| Active ingredients | Purpose |
|---|---|
| Benzocaine 20.0% (w/w) | Oral anesthetic/analgesic (oral pain reliever) |
| Menthol 2.0% (w/w) | Oral anesthetic/analgesic (oral pain reliever) |
Uses
- for the temporary relief of pain associated with canker sores, minor irritation of the mouth and gums caused by dentures or orthodontic appliances, or minor injury of the mouth or gums.
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.
Do Not Use
- for teething
- in children under 2 years of age
When Using This Product
- do not use this product for more than 7 days unless directed by a dentist or doctor. If sore mouth symptoms do not improve in 7 days; if irritation, pain, or redness persists or worsens; or if swelling, rash or fever develops, see your dentist or doctor promptly.
- do not exceed recommended dosage.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Directions
| Adults and children 2 years of age and older | Apply to affected area up to 4 times daily or as directed by a dentist or doctor |
| Children between 2 and 12 years of age | Ask a doctor before use. Should be supervised in the use of this product |
| Children under 2 years of age | Do not use |
Other Information
- www.kank-a.com
Inactive Ingredients
ascorbyl palmitate, cetylpyridinium chloride, PEG-75, phenoxyethanol, polyethylene glycol, sucralose, thymol
Principal Display Panel - 11.9 G Tube Carton
MAXIMUM STRENGTH
KANKA®
TRIPLE ACTION GEL
ORAL PAIN RELIEVER
Mouth Pain Relief for Canker Sores
Net Wt. 0.42 oz. (11.9 g)
Principal Display Panel (11.9 g Tube Carton)
* Please review the disclaimer below.
