Anticavity Mouthwash
FDA Label NDC 72476-005

12 label sections · Submitted to the FDA by Adusa Distribution, Llc · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Adusa Distribution, Llc for the product Anticavity (NDC 72476-005). 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 tamper evident statement, active ingredient, purpose, use, warnings, keep out of reach of children., directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Tamper Evident Statement

Sealed With Printed Neckband For Your Protection

Active Ingredient

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

Purpose

Anticavity

Use

aids in the prevention of dental cavities

Warnings

for this product

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 12 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 and then spit out
  • do not swallow the rinse
  • do not eat or drink for 30 minutes after rinsing
  • instruct children under 12 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 20⁰ - 25⁰ C(68⁰ - 77⁰ F)
  • cold weather may temporarily cloud this product

Inactive Ingredients

water, alcohol (21.6 %v/v), sorbitol, poloxamer 407, eucalyptol, flavor, methyl salicylate, menthol, phosphoric acid, sodium saccharin, thymol, disodium phosphate, sucralose, red 40, blue 1

Disclaimer

*This product is not manufactured or distributed by Kenvue, Inc., distributor of Listerine ® Total Care Fresh Mint Anticavity Mouthwash.

Adverse Reaction

DISTRIBUTED BY: ADUSA DISTRIBUTION, LLC

SALISBURY, NC 28147 1-833-992-3872

Quality guaranteed or your money back.

DSP-TN-21091

DSP-MO-20087

Principal Display Panel

CARE ONE ®

Compare to Listerine ® Total Care Fresh Mint Anticavity Mouthwash*

ANTICAVITY

MOUTHWASH

SODIUM FLUORIDE & ACIDULATED PHOSPHATE TOPICAL SOLUTION

Helps prevent cavities and restore enamel

Helps strengthen teeth 

Freshens breath

Mint Flavor

IMPORTANT: Read directions for proper use.

33.8 FL OZ (1.05 QT) 1 L

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