Q2 Oral Care Kit
FDA Label NDC 69697-983

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 Q2 Oral Care Kit (NDC 69697-983). 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, stop use and ask a doctor if, 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

Drug Facts

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

Active Ingredient

Hydrogen Peroxide 1.5%

Purpose

Oral Debriding Agent

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.

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.

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.

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.

Other Information

  • Store at room temperature.

Inactive Ingredients

Purified Water, Glycerin, Flavor, Sodium Saccharin

Questions Or Comments?

1-844-425-9273

Principal Display Panel - Kit Carton

HALYARD*

24-HOUR
ORAL CARE KIT

with BALLARD* Technology

with
H2O2

q2

1
HALYARD*
Prep
Pack

2
HALYARD*
Toothbrush
Packs

4
HALYARD*
Suction Swab
Packs with H2O2

6
HALYARD*
Suction Swab Packs
with Alcohol-Free Mouthwash

2
HALYARD*
Suction Catheter
Packs

Principal Display Panel (Kit Carton)

Principal Display Panel (Kit Carton)

* Please review the disclaimer below.