Cvs Pharmacy Gel, Dentifrice
FDA Label NDC 59779-582

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy for the product Cvs Pharmacy (NDC 59779-582). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, use, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Benzocaine 20.0% w/w...................................................................... Oral anesthetic

Use

temporarily relieves pain associated with mouth and gum irritations

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

  • 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

    • 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

Otc - Keep Out Of Reach Of Children

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.

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.

Other Information

Store at 20-25C (68-77F). Do not refrigerate

Inactive Ingredients

Blue 1, Carbomer, Flavor, Glycerin, Polyethylene Glycol, Propylene Glycol, Red 40, Sodium Saccharin, Sorbic Acid, Water, Yellow 10

Package Label.Principal Display Panel

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