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NDC 10157-2106-02 KANKA 20; .1 mg/100g; g/100g Details
KANKA 20; .1 mg/100g; g/100g
KANKA is a ORAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Blistex Inc. The primary component is BENZOCAINE; ZINC CHLORIDE.
Product Information
| NDC | 10157-2106 |
|---|---|
| Product ID | 10157-2106_63ce9e63-4c32-40c4-a18e-3daae1860150 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | KANKA |
| Proprietary Name Suffix | SoftBrush |
| Non-Proprietary Name | Benzocaine and ZINC CHLORIDE |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | GEL |
| Route | ORAL |
| Active Ingredient Strength | 20; .1 |
| Active Ingredient Units | mg/100g; g/100g |
| Substance Name | BENZOCAINE; ZINC CHLORIDE |
| Labeler Name | Blistex Inc |
| Pharmaceutical Class | Allergens [CS], Cell-mediated Immunity [PE], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH NOT FINAL |
| Application Number | part356 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 10157-2106-02 (10157210602)
| NDC Package Code | 10157-2106-2 |
|---|---|
| Billing NDC | 10157210602 |
| Package | 2 APPLICATOR in 1 BLISTER PACK (10157-2106-2) / 2 g in 1 APPLICATOR |
| Marketing Start Date | 2019-09-25 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 093f3545-1d8e-48a3-a533-e9c3ae6d740b Details
SPL UNCLASSIFIED SECTION
Uses
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.
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.
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
PRINCIPAL DISPLAY PANEL - 2.0 g Applicator Blister Pack
INGREDIENTS AND APPEARANCE
| KANKA
SOFTBRUSH
benzocaine and zinc chloride gel |
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| Labeler - Blistex Inc (005126354) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Blistex Inc | 005126354 | MANUFACTURE(10157-2106) | |
Revised: 9/2019
Document Id: 63ce9e63-4c32-40c4-a18e-3daae1860150
Set id: 093f3545-1d8e-48a3-a533-e9c3ae6d740b
Version: 1
Effective Time: 20190927