Anticavity
FDA Label NDC 11822-5927

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rite Aid Corporation for the product Anticavity (NDC 11822-5927). 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, warnings, keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Sodium fluoride 0.0221% (0.01% w/v fluoride ion)

Purpose

Anticavity

Use

aids in the prevention of dental cavities

Warnings

Warnings

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 daily after brushing your teeth with a toothpaste
  • vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute then spit out
  • do not swallow the rinse
  • do not eat or drink for 30 minutes after rinsing
  • instruct children uder 12 years of age in good rinsing habits (to minimize swallowing)
  • supervise children as necessary until capable of using without supervision
  • children under 6 years of age: consult a dentist or doctor

Other Information

  • store at controlled room temperature 20°-25° C to (68° - 77°F)
  • cold weather may temporarily cloud this product

Inactive Ingredients

water, alcohol (21.6%), sorbitol, poloxamer 407, sodium lauryl sulfate, eucalyptol, flavor, methyl salicylate, thymol, phosphoric acid, sucralose, menthol, disodium posphate, red 40, blue 1

Adverse Reaction Section

*This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of Listerine Total Care Fresh Mint Anticavity Mouthwash

DISTRIBUTED BY:
RITE AID, 30 HUNTER LANE
CAMP HILL, PA 17011
IF YOU ARE NOT SATISFIED, WE'LL HAPPILY REFUND YOUR MONEY.

Principal Display Panel

RITE AID PHARMACY

Sealed With Printed Neckband For Your Protection

IMPORTANT: READ DIRECTIONS FOR PROPER USE

Compare to the active ingredent in Listerine Total Care Anticavity Mouthwash

Anticavity mouthwash

Sodium Fluoride and Acidulated Phosphate Topical Solution

Multiple Benefits In One

helps preventcavities

restores enamel

helps strengthen teeth

helps kill bad breath

leaves the mouth feeling clean

Mint

1 Liter (33.8 FL OZ)

163.004/163AE

Image Description (Mm3)

Image Description (Mm3)

* Please review the disclaimer below.