Anticavity Mouthwash
FDA Label NDC 36800-803

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Anticavity (NDC 36800-803). 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, inactive ingredients, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Sodium fluoride 0.02% (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 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 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

Inactive Ingredients

water, alcohol (8%), hydrogen peroxide, poloxamer 407, sodium saccharin, sucralose, menthol, phosphoric acid, disodium phosphate, flavor

Other Information

  • store at room temperature (59°-77°F)

    • Contains peroxide which releases oxygen while whitening.  This may cause the bottle to inflate slightly or release air when opened.

Disclaimer

*This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of Listerine Healthy White Vibrant Anticavity Mouthrinse

Adverse Reactions

DISTRIBUTED BY TOPCO ASSOCIATES, LLC

ELK GROVE VILLAGE, IL 60007

[email protected]    www.topcarebrand.com

435.000/435AA

Principal Display Panel

TopCare

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

FRESH MINT FLAVOR

Glowing

White

Anticavity

Mouthrinse

  • Begins working on contact
  • 5 days to whiter teeth
  • Helps strengthen teeth
  • Kills germs that cause bad breath

    • IMPORTANT:

    read direction for proper use.

    COMPARE TO LISTERINE HEALTHYWHITE ANTICAVITY MOUTHRINSE active ingredient

    16 FL OZ (1 PT) 474 mL

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* Please review the disclaimer below.