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| Product NDC Code | 59779-582 | ||||
|---|---|---|---|---|---|
| Drug Name | Cvs pharmacy maximum 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 | GEL, DENTIFRICE | ||||
| RxCUI drug identifier | 238910 | ||||
| Application Number | part356 | ||||
| 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%
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 open tube, cut tip of tube on score mark. adults and children 2 years of age and older: apply to affected area up to 4 times daily or as directed by dentist/doctor. children under 12 years of age: adult supervision should be given in the use of this product. children under 2 years of age: consult a doctor / dentist. for denture irritation apply a thin layer to the affected area; do not reinsert dental work intil irritation/pain is relieved; rinse mouth well after reinserting
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Blue 1, Carbomer, Flavor, Glycerin, Polyethylene Glycol, Propylene Glycol, Red 40, Sodium Saccharin, Sorbic Acid, Water, Yellow 10
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.Use temporarily relieves pain associated with mouth and gum irritations
Purpose
Information about the drug product’s indications for use.Purpose Oral anesthetic
Spl product data elements
Usually a list of ingredients in a drug product.CVS Pharmacy Maximum Strength Benzocaine POLYETHYLENE GLYCOL 400 PROPYLENE GLYCOL SACCHARIN SODIUM SORBIC ACID GLYCERIN FD&C RED NO. 40 D&C YELLOW NO. 10 FD&C BLUE NO. 1 WATER BENZOCAINE BENZOCAINE Characteristic Mint
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 R5
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.
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a dentist or doctor if sore mouth symptoms do not get better in 7 days irritation, pain or redness persists or worsens swelling, rash or fever develops
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 avoid contact with eyes. do not exceed recommended dosage. do not use for more than 7 days unless directed by doctor / dentist
Storage and handling
Information about safe storage and handling of the drug product.Other Information Store at 20-25C (68-77F). Do not refrigerate
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 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 Stop use and ask a dentist or doctor if sore mouth symptoms do not get better in 7 days irritation, pain or redness persists or worsens swelling, rash or fever develops When using this product avoid contact with eyes. do not exceed recommended dosage. do not use for more than 7 days unless directed by doctor / dentist 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