Kimvent Oral Care Toothbrush Pack
FDA Label NDC 69697-980

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Halyard Health for the product Kimvent Oral Care Toothbrush Pack (NDC 69697-980). 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 other, active ingredient, purpose, uses, otc - stop use, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Distributed in the U.S. by Kimberly-Clark Global Sales, LLC, Roswell, GA 30076 USA

Active Ingredient

Cetylpyridinium Chloride 0.05

Purpose

Antigingivitis/Antiplaque

Uses

  • Helps remove plaque that leads to gingivitis.

Otc - Stop Use

Stop use and ask a doctor if:

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

Otc - Keep Out Of Reach Of Children

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 12 years of age and older: Use as directed by a dentist. Do not swallow the rinse.
  • Children 6 years to under 12 years of age: supervised use.
  • Children under 6 years of age: do not use.
  • Use only under health care practitioner's supervision.

Other Information

  • This rinse is not intended to replace brushing or flossing.
  • Store at room temperature.

Inactive Ingredients

Purified Water, Glycerin, Sorbitol, Flavor, Benzoic Acid, Sodium Benzoate, Sodium Saccharin, D&C Green 5

Questions Or Comments?

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Kimberly-Clark*

KimVent*
Toothbrush
Pack with Antiplaque
Solution

Contains:

  • 1 Suction Toothbrush
  • 1 Applicator Swab
  • 0.5 fl. oz. (14mL) of 0.05% Antiplaque Solution
  • 0.07 oz. (2g) Mouth Moisturizer
    Purified Water, Propylene Glycol Sorbitol, Hydroxypropyl Methylcellulose, Dimethicone, Flavor,
    Xylitol, Aloe Vera Gel, Potassium Sorbate, Sodium Benzoate, Potassium Chloride, Sodium Chloride
    • Principal Display Panel (Kit Carton)

    Principal Display Panel (Kit Carton)

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