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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 | 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%
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 with scissors adults and children 2 years of age and over: apply a pea-size amount to the affected area up to 4 times daily or as directed by a 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: do not use 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, toothache, sore gums, canker sores, braces, minor dental procedures, dentures
Purpose
Information about the drug product’s indications for use.Purpose Oral pain reliever
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.2821636 CVS Health Oral Pain
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.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 (1-800-222-1222).
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.Methemoglobinemia Warning : USe of this product may cause methemoglobinemia, a rare but 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.
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