Cvs Paste, Dentifrice
FDA Label NDC 59779-123

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 (NDC 59779-123). 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, dosage & administration, 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% ...................................................................... Oral pain reliever

Use

for the temporary relief of pain due to toothache

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

  • Do not use more than directed for more than 7 days unless directed by a dentist or doctor.
  • Stop use and ask a doctor if swelling, rash or fever develops, irritation, pain or redness persists or worsens

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

• cut open tip of tube on scoremark

  • Adults and children 2 years of age and older: apply a small amount of product to the cavity and around the the gum surrounding the teeth. Use up to 4 times daily or as directed by a dentist or doctor. CDhildren under 12 years of age should be supervised in the use of this product.
  • children under 2 years of age: ask a dentist or doctor.

Other Information

Do not use if tip is cut prior to opening. This preparation is intended for use in cases of toothache, only as a tempory expedient until a dentist can be consulted. Do not use continuously. This formula will stay in place for extended duration of relief.

Inactive Ingredients

Cellulose Gum, Gelatin, Menthol, Methyl Salicylate, Pectin, Petrolatum, Polyethylene Glycol, Sodium Saccharin.

Dosage & Administration

• 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

Package Label.Principal Display Panel

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