Oral Care Q4 Kit
FDA Label NDC 69697-986

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 Oral Care Q4 Kit (NDC 69697-986). 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 - do not use, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Oral Debriding Agent

Drug Facts

 

Antiplaque Solution

Drug Facts

Manufactured by Kimberly-Clark, Roswell, GA 30076 USA

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

Active Ingredient

Hydrogen Peroxide 1.5%

Cetylpyridinium Chloride 0.05%

Purpose

Oral Debriding Agent

Antigingivitis/Antiplaque

Uses

  • Aids in the removal of phlegm, mucus, or other secretions in the temporary relief of discomfort due to occasional sore throat and sore mouth.
    • Helps remove plaque that leads to gingivitis.

Otc - Stop Use

Stop use and ask a doctor if:

  • Swelling, rash, or fever develop.
  • Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting occurs.

    • 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 - Do Not Use

  • Do not use more than 2 days or administer to children under 3 years of age unless directed by a physician.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children under 3 years of age.

Keep out of reach of children under 6 years of age.

If more than used for rinsing is accidently swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Topical dosage for adults and children 3 years of age and older is a rinse used no more than 4 times daily. For children under 3 years of age, there is no recommended dosage except under the advice and supervision of a dentist or doctor.
  • Use only under health care practitioners supervision.
    • 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

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

Inactive Ingredients

Purified Water, Glycerin, Flavor, Sodium Saccharin

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

Questions Or Comments?

1-800-KCHELPS

1-844-425-9273

Principal Display Panel - Kit Carton

HALYARD*

24-HOUR
ORAL CARE KIT
with BALLARD* Technology

q4

1
HALYARD*
Prep
Pack

2
HALYARD*
Toothbrush
Packs

4
HALYARD*
Suction Swab
Packs with H2O2

2
HALYARD*
Suction Catheter
Packs

Principal Display Panel (Kit Carton)

Principal Display Panel (Kit Carton)

* Please review the disclaimer below.