Anticavity Mouthwash
FDA Label NDC 55910-163

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Old East Main Co. for the product Anticavity (NDC 55910-163). 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 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.

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 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- 25⁰C (68⁰- 77⁰F )

  • cold weather may temporarily cloud this product

Inactive Ingredients

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

Other

Sealed with printed neckband for your protection.

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

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(888)309-9030

DISTRIBUTED BY OLD EAST MAIN CO.

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

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Compare to Listerine Total Care Fresh Mint Anticavity Mouthwash

ANTICAVITY FLUORIDE MOUTHWASH

Sodium Fluoride and Acidulated Posphate Topical Solution

EUCALYPTUS MINT

MULTIPLE BENEFITS IN ONE

  • Freshens Breath
  • Restores Enamel
  • Helps Prevent Cavities
  • Kills Bad Breadh Germs
  • Helps Strengthen Teeth
  • IMPORTANT: read directions for proper use

    1 L (33.8 FL OZ)

    163.004/163AE

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Since 1903

Rexall

Anticavity

Fluoride

Mouthwash

Sodium Fluoride and Acidulated Phosphate Topical Solution

  • Helps prevent cavities and restore enamel
  • Kills bad breath germs
  • Eucalyptus mint flavor
  • IMPORTANT: read directions for proper use.

    1 L (1 QT 1.8 FL OZ) 33.8 FL OZ

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    Image Description (Mm3)

* Please review the disclaimer below.