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NDC 27854-0178-01 AnaDent Childrens Kanka Gel 12 mg/g Details
AnaDent Childrens Kanka Gel 12 mg/g
AnaDent Childrens Kanka Gel is a DENTAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Belmora LLC. The primary component is EUGENOL.
Product Information
| NDC | 27854-0178 |
|---|---|
| Product ID | 27854-178_d2dfd707-8d68-45dd-9e32-d7cc34a500be |
| 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 Childrens Kanka Gel |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Eugenol |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | GEL |
| Route | DENTAL |
| Active Ingredient Strength | 12 |
| Active Ingredient Units | mg/g |
| Substance Name | EUGENOL |
| 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 27854-0178-01 (27854017801)
| NDC Package Code | 27854-178-01 |
|---|---|
| Billing NDC | 27854017801 |
| Package | 1 TUBE in 1 CARTON (27854-178-01) / 7 g in 1 TUBE |
| Marketing Start Date | 2022-11-08 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 9c06211c-f05a-4ce7-89e5-63a63efb7f96 Details
Warnings:
For external use only.
Allergy alert: Do not use if you are allergic to eugenol (clove oil).
When using this product
• use only in teeth with persistent throbbing pain
• DO NOT SWALLOW to avoid irritation • avoid contact with eyes
Do not use
• for more than 7 days • more than the recommended dose
Stop use and ask a dentist or doctor if
• irritation persists • inflammation develops • fever and infection develop
Directions
• Adults and children 2 to 12 years of age and older: Moisten a cotton pellet with 1 or 2 drops of the product and then apply to the cotton pellet on the applicable tooth. Avoid touching tissues other than the tooth cavity. Apply the dose not more than four times daily or as directed by a dentist or physician.
• Children 2 to 12 years of age: should be supervised in the use of this product. Children under 2 years of age: use only under the advice of a dentist or physician.
Other Information
Inactive Ingredients:
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
| ANADENT CHILDRENS KANKA GEL
eugenol gel |
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| Labeler - Belmora LLC (112753244) |