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| Product NDC Code | 59779-830 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Mouth sore relief professional strength |
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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 | ORAL | ||||||
| Dosage Form | LIQUID | ||||||
| RxCUI drug identifier | 308657 | ||||||
| Application Number | M022 | ||||||
| Labeler Name | CVS Pharmacy | ||||||
| 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% (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 to assure formation of 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: consult a dentist or doctor
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, PEG-6, Propylene Glycol, Ricinus Communis (Castor) Seed Oil, SD Alcohol 38B, 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.Mouth Sore Relief Professional Strength Benzocaine ALCOHOL ETHYLCELLULOSES TANNIC ACID CETYLPYRIDINIUM CHLORIDE SUCRALOSE BENZYL ALCOHOL PROPYLENE GLYCOL OLETH-10 DIMETHYL ISOSORBIDE RICINUS COMMUNIS SEED POLYETHYLENE GLYCOL 300 BENZOIN, (+/-) BENZOCAINE BENZOCAINE Mint Flavor #25797
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.Card R8
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 swallowed, get medical help or contact a Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information • do not use if package has been opened • store at 20-25˚C (68-77°F) • close cap tightly after use to avoid evaporation • avoid contact with 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.For oral use only 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 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 doctor or dentist promptly. Do not exceed recommended dosage. Keep out of reach of children. If 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