Oral Antivavity Mouthwash
FDA Label NDC 76162-576

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 Oral Antivavity (NDC 76162-576). 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 claims, active ingredient, purpose, use, warnings, keep out of reach of children, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Claims

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECION

TopCare

everyday

  • Helps strengthen enamel
  • Helps prevent cavities
  • Kills bad breath germs
  • Freshen Breath

Active Ingredient

Sodium fluoride 0.0219% (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 bwtween 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 under 12 years of age in good rinsing habits (to minimize swallowing)
  • supervise children as necessary until capable of using witout supervision
  • children under 6 years of age: consult a dentist or doctor

Inactive Ingredients

water, glycerin, flavor, cetylpyridinium chloride, sodium saccharin, phosphoric acid, sodium benzoate, sucralose, poloxamer 407, benzoic acid, disodium phosphate, propylene glycol, blue 1

Questions?

Call 1-888-423-0139

Other

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLATE, IL 60007

©TOPCO VIJA0122  QUESTIONS? 1-888-423-0139

This rinse may cause temporary staining to the surface of teeth. This is not harmful, add adequate brushing may prevent its occurence

This product is not manufactured or distributed by Procter & Gamble, distributof of Crest Pro-Health Advanced Anticavity Fluoride Mouthwash

This product is not intended to replace brushing or flossing

Principal Display Panel

COMPARE TO CREST PRO-HEALTH ADVANCED ANTICAVITY FLUORIDE MOUTHWASH

TopCare

everyday

ALOHOL FREE

Fluoride

Anticavity Mouthwash

REFRESHING MINT

  • Helps strengthen enamel
  • Helps prevent cavities
  • Cleans teeth**
  • Kills bad breath germs
  • Freshens breath
  • Helps keep mouth feeling clean

    • IMPORTANT: Read directions for proper use.

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

    Image Description (Mm3)

    Image Description (Mm3)

* Please review the disclaimer below.