Anticavity Fluoride
FDA Label NDC 69842-429

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 Anticavity Fluoride (NDC 69842-429). 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, purpose, use, keep out of reach of children., directions, other information, inactive ingredients, principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient

Sodium Fluoride 0.02% (0.01% w/v fluoride ion)

Purpose

Anticavity

Use

Aids in the prevention of dental cavities

Keep Out Of Reach Of Children.

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 6 years of age and older: Use twice a day after brushing your teeth with a toothpaste.

Vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out.

Do not swallow the rinse.

Do not eat or drink for 30 minutes after rinsing.

Instruct children 12 years of age in good rinsing habits (to minimize swallowing).

Supervise children as necessary until capable of using without supervision.

Close cap fully after use, until the cap is felt to “click”, to reengage the child resistant cap.

Children under 6 years of age: Consult a dentist or doctor

Other Information

Store at room temperature. Cold temperature may temporarily cloud this product.

Inactive Ingredients

water, glycerin, flavor, cetylpyridinium chloride, sodium saccharin, phosphoric acid, methylparaben, poloxamer 407, propylparaben, disodium phosphate, blue 1

This rinse may cause temporary staining to the surface of teeth.

This is not harmful and adequate brushing may prevent its occurrence.

Principal Display Panel

Anticavity Fluoride
Mouthwash
Sodium Fluoride Oral Solution
Minty Fresh
33.8 FL OZ (1 L)

Principal Display Panelanticavity Fluoridemouthwashsodium Fluoride Oral Solutionminty Fresh33.8 Fl Oz (1 L) (Anticavity Fluoride Mouthwash 01)

Principal Display Panelanticavity Fluoridemouthwashsodium Fluoride Oral Solutionminty Fresh33.8 Fl Oz (1 L) (Anticavity Fluoride Mouthwash 01)

* Please review the disclaimer below.