NDC 69697-986 Oral Care Q4 Kit

Product Information

Product Code69697-986
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Oral Care Q4 Kit
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Halyard Health
Labeler Code69697
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
03-13-2008
Listing Expiration Date What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
12-31-2019
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
I
NDC Code Structure

Usage Information


Product Characteristics

Color(s)BLUE (C48333)
Flavor(s)MINT (C73404)

Product Packages

NDC 69697-986-01

Package Description: 1 KIT in 1 CARTON * 14 mL in 1 CUP, UNIT-DOSE * 10 g in 1 TUBE * 14 mL in 1 CUP, UNIT-DOSE

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Product Details

Oral Care Q4 Kit is product labeled by Halyard Health. The product's dosage form is and is administered via form.


What are Oral Care Q4 Kit Active Ingredients?

The following is the list of active ingredients in this product. An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

  • HYDROGEN PEROXIDE (UNII: BBX060AN9V)
  • HYDROGEN PEROXIDE (UNII: BBX060AN9V) (Active Moiety)
  • CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
  • CETYLPYRIDINIUM (UNII: CUB7JI0JV3) (Active Moiety)


NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct code indicates a single concept unique identifier (RXCUI) is associated with this product:


Inactive Ingredient(s)

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • MINT (UNII: FV98Z8GITP)
  • SACCHARIN SODIUM DIHYDRATE (UNII: SB8ZUX40TY)
  • WATER (UNII: 059QF0KO0R)
  • BENZOIC ACID (UNII: 8SKN0B0MIM)
  • SACCHARIN SODIUM DIHYDRATE (UNII: SB8ZUX40TY)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)
  • SORBITOL (UNII: 506T60A25R)
  • MINT (UNII: FV98Z8GITP)


* Please review the disclaimer below.

Oral Care Q4 Kit Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



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


* Please review the disclaimer below.