Antiseptic Rinse
FDA Label NDC 36800-299

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 Antiseptic (NDC 36800-299). 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, stop use and ask a dentist if, keep out of reach of children under 6 years of age., directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Cetylpyridinium chloride 0.07%

Purpose

Antigingivitis, Antiplaque

Use

helps control plaque that leads to gingivitis

Warnings

for this product only

Stop Use And Ask A Dentist If

  • gingivitis, bleeding or redness persists for more than 2 weeks
  • you have painful or swollen gums, pus from the gun line, loose teeth or increased spacing between the teeth.  These may be signs or symptoms of periodontitis, a serious form of gum disease.

Keep Out Of Reach Of Children Under 6 Years Of Age.

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 & older: rinse for 30 seconds with 20 mL (4 teaspoonfuls) twice a day
  • do not swallow
  • children 6 years to under 12 years of age: supervise use
  • children under 6 years of age: do not use

Other Information

  • this rinse is not intended to replace brushing or flossing

Inactive Ingredients

water, glycerin, flavor, poloxamer 188, sodium saccharin, propylene glycol, sodium benzoate, sucralose, benzoic acid, blue 1

Disclaimer

This product is not manufactured or distributed by
Procter & Gamble distributor of Crest Pro-Health Rinse

Adverse Reactions

DISTRIBUTED BY TOPCO ASSOCIATES, LLC
ELK GROOVE VILLAGE, IL 60077
QUESTIONS? 1-888-423-0139
[email protected]

Principal Display Panel

Sealed With Printed Neckband For Your Protection

TopCare

ALCOHOL

FREE

Oral

Health

Rinse

ANTISEPTIC

Antigingivitis/Antiplaque

  • Kills germs
  • Helps prevent plaque
  • Helps prevent gingivitis
  • Helps keep teeth feeling clean
  • No burn of alcohol
  • Freshens breath

    • Mint Flavor

    QUALITY

    GUARANTED

    COMPARE TO ACTIVE INGREDIENT

    OF CREST PRO-HEALTH RINSE

    33.8 FL OZ

    (1 QT 1.8 FL OZ) 1 L

    Image Description (Mm3)

    Image Description (Mm3)

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