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NDC 27854-0177-01 Anadent Kanka Gel 200 mg/g Details
Anadent Kanka Gel 200 mg/g
Anadent Kanka Gel is a DENTAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by BELMORA LLC. The primary component is BENZOCAINE.
Product Information
| NDC | 27854-0177 |
|---|---|
| Product ID | 27854-177_808e52ba-b263-4218-96ac-6712279a630c |
| 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 | Anadent Kanka Gel |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Benzocaine |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | GEL |
| Route | DENTAL |
| Active Ingredient Strength | 200 |
| Active Ingredient Units | mg/g |
| Substance Name | BENZOCAINE |
| Labeler Name | BELMORA LLC |
| Pharmaceutical Class | Allergens [CS], Cell-mediated Immunity [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 27854-0177-01 (27854017701)
| NDC Package Code | 27854-177-01 |
|---|---|
| Billing NDC | 27854017701 |
| Package | 1 TUBE in 1 CARTON (27854-177-01) / 7 g in 1 TUBE |
| Marketing Start Date | 2022-04-15 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL e0f73d78-5db1-43b4-8f58-e5410ca4560f Details
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
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
Stop use and ask a dentist or doctor if
- swelling, rash or fever develops • irritation, pain or redness persists or worsens
- symptoms do not improve in 7 days • allergic reaction occurs
Directions
- Cut open tip of tube on score mark
- Adults and children 2 years of age and older: apply a small amount of product to the cavity and around 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 Information
- Do not use if tip is cut prior to opening
- This preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist can be consulted
- Do not use continuously
- This formula will stay in place for extended duration of relief
- Avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying
Inactive Ingredients:
SPL UNCLASSIFIED SECTION
20% BENZOCAINE TO RELIEVE ORAL PAIN
COOLS GUM & RELIEVES IRRITATION
For toothaches
Toothache and Gum pain Relief Gel
TAMPER-EVIDENT:
Do not use if tube is cut prior to use.
Retain carton for complete product information.
Distributed by Belmora LLC, 3033 Wilson Blvd. Suite 700 Arlington, VA 22201 | www.anadentusa.com
Questions/Comments please call: 1 888 779 2877 Monday to Friday 9AM - 5PM EST
INGREDIENTS AND APPEARANCE
| ANADENT KANKA GEL
benzocaine gel |
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| Labeler - BELMORA LLC (112753244) |