Anticavity Fluoride Rinse Mouthwash
FDA Label NDC 37808-163

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by H E B for the product Anticavity Fluoride Rinse (NDC 37808-163). 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 tep, 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.

Tep

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

Active Ingredient

Sodium fluoride 0.0221% (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 6 years of age and older:

  • use twice daily after brushing your teeth with 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 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 20⁰ -25⁰ C (68⁰ - 77⁰ 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, disosium phosphate, red 40, blue 1

Questions?

Call 1-888-593-0593

Other

This product is not manufacturd or distributed by Johnson & Johnson Healthcare Products, distributor of Listerine Total Care Anticavity Mouthwash

MADE WITH PRIDE AND CARE FOR H-E-B, SAN ANTONIO, TX 78204

163.004/163AE

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Compare to Listerine Total Care

Anticavity Mouthwash

H-E-B

Mint

ANTICAVITY MOUTHWASH

SODIUM FLUORIDE AND ACIDULATED PHOSPHATE TOPICAL SOLUTION

  • Kills Germs That Cause Bad Breath
  • Helps Prevent Cavities
  • IMPORTANT: read directions for proper use.

    33.8 FL OZ (1 QT) 1L

    Image Description (Mm3)

    Image Description (Mm3)

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