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| Product NDC Code | 10157-9477 | ||||
|---|---|---|---|---|---|
| Drug Name | Kank-a mouth pain |
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| Type | Brand | ||||
| Pharm Class | Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC] |
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| Active Ingredients |
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| Route | BUCCAL | ||||
| Dosage Form | LIQUID | ||||
| RxCUI drug identifier | 308657 | ||||
| Application Number | M015 | ||||
| Labeler Name | Blistex Inc. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Benzocaine 20.0% (w/w)
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions adults and children 2 years of age and older: to assure formation of a long-lasting film coating, dry affected area and apply medication undiluted with applicator allow a few seconds for coating to form 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
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients benzyl alcohol, cetylpyridinium chloride, compound benzoin tincture, dimethyl isosorbide, ethylcellulose, flavor, octylacrylamide/acrylates/butylaminoethyl methacrylate copolymer, oleth-10, polyethylene glycol, propylene glycol, ricinus communis (castor) seed oil, SD alcohol 38-B (29.6% v/v), sodium saccharin, sucralose, tannic acid
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses for the temporary relief of pain due to canker sores, minor irritation of the mouth and gums caused by dentures or orthodontic appliances, or minor injury of the mouth or gums
Purpose
Information about the drug product’s indications for use.Purpose Oral anesthetic/analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Kank-A Mouth Pain Benzocaine Benzocaine Benzocaine BENZYL ALCOHOL CETYLPYRIDINIUM CHLORIDE compound benzoin tincture DIMETHYL ISOSORBIDE ETHYLCELLULOSE, UNSPECIFIED ACRYLATE/BUTYLAMINOETHYL METHACRYLATE/METHYL ACRYLATE/METHYL METHACRYLATE/OCTYLACRYLAMIDE COPOLYMER (40000 WAMW) OLETH-10 POLYETHYLENE GLYCOL, UNSPECIFIED POLYETHYLENE GLYCOL 300 PROPYLENE GLYCOL CASTOR OIL ALCOHOL SACCHARIN SODIUM SUCRALOSE TANNIC ACID
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PRINCIPAL DISPLAY PANEL - 9.75 mL Bottle Package MAXIMUM STRENGTH KANK-A ® MOUTH PAIN LIQUID ORAL ANESTHETIC Maximum Pain Relief Forms Protective Coating For Sores Inside the Mouth Canker Sores Denture Abrasions Brace Irritation ADA Accepted American Dental Association ® CONVENIENT CONTROL-TIP APPLICATOR Net 0.33 fl. oz. (9.75 mL) Principal Display Panel - 9.75 mL Bottle Package
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.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
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.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.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.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.
Storage and handling
Information about safe storage and handling of the drug product.Other information do not purchase if package has been opened cap tightly after use to avoid evaporation avoid contact with the eyes avoid contact with clothing and household/furniture surfaces to prevent possible staining this is a personal care item, and should be used by one individual only
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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 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. 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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API