Other
Drug Facts
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.
Kanka Gel
FDA Label NDC 10157-2106
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 (NDC 10157-2106). 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, do not use, when using this product, otc - 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
Otc - Purpose
| Active ingredients | Purpose |
|---|---|
| Benzocaine 20.0% (w/w) | Oral anesthetic/analgesic |
| Zinc Chloride 0.1% (w/w) | Oral astringent |
Uses
- for the temporary relief of pain due to toothaches, 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
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:
- twist base clockwise to dispense. It may take up to 10 full turns to dispense the initial dose, but subsequent uses should require less than 1 turn.
- to clean brush tip, rinse with cold water
- dry affected area and apply medication by gently brushing 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: do not use
Other Information
- do not purchase if package has been opened
- replace cap after use to prevent drying
- avoid contact with the eyes
- this is a personal care item, and should be used by one individual only
- with zinc chloride, some color may be evident; this is normal
Inactive Ingredients
flavors, glycerin, PEG-8, PEG-75, phenoxyethanol, silica, sucralose
Principal Display Panel - 2.0 G Applicator Blister Pack
Blistex®
MAXIMUM STRENGTH
KANKA®
Soft Brush®
Tooth & Gum Pain Gel
ORAL ANESTHETIC/ASTRINGENT
Maximum Pain Relief
Dual Medications
Gentle Application
Easy Reach Design
Ultra Soft Tip
50+ Uses
Toothaches
Brace/Denture Irritation
Gum Discomfort
Canker Sores
Net Wt.
0.07 oz. (2.0 g)
Principal Display Panel (2.0 g Applicator Blister Pack)
* Please review the disclaimer below.
