Mouth Rinse Mouthwash
FDA Label NDC 36800-001

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 Mouth Rinse (NDC 36800-001). 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.

Label Section Quick Index

Active Ingredient

Sodium fluoride 0.0221% (0.01% 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 under 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 anything for 30 minutes after rinsing

•supervise children as necessary until capable of using without supervision

•children under 12 years of age: consult a dentist or doctor

Other Information

•store at controlled room temperature 20⁰ - 25⁰C (68⁰ - 77⁰ F)

•cold weather may temporarily cloud this product

Inactive Ingredients

water, sorbitol solution, alcohol (21.6%), flavors, poloxamer 407 sodium lauryl sulfate, phosphoric acid, sucralose and /or sodium saccharin, dibasic sodium phosphate, D+C red no.33, FD+C blue no.1, FD+C yellow no. 6

Disclaimer

*This product is not manufactured or distributed by Johnson + Johnson Healthcare Products, distributed of Listerine Total Care

DISTRIBUTED BY TOPCO ASSOCIATES LLC
7711 GROSS POINT ROAD, SKOKIE, IL 60077
TOPCO VIJ910
QUESTIONS? 1-888-423-0139 [email protected]
This TOP CARE product is laboratory tested to guarantee its hightes quality. Your total satisfaction is guaranteed
DSP-TN 15000
DSP-MO-34
SDS-TN-15012

Principal Display Panel

Sealed With Printed Neckband For Your Protection

Kills Germs and Freshens Breath

IMPORTANT: read directions for proper use.

Anticavity Mouthwash

SODIUM FLUORIDE AND ACIDULATED PHOSPHATE TOPICAL  SOLUTION

  • Helps prevent cavities
  • Restores enamel
  • Helps strengthen teeth
  • Helps kill germs that casue bad breath
  • Freshens breath

    • Eucalyptus Mint

    COMPARE TO ACTIVE INGREDIENT OF LISTERINE TOTAL CARE ANTICAVITY MOUTHWASH

    1 L (33.8 FL OZ)

    163.004/163AE

* Please review the disclaimer below.