FDA.reportPublic FDA data

Q2 Oral Care Kit

Manufacturer
Halyard Health | Avent | Elba | Hi Tech Pharmacal
Effective date
2016-01-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:44:57

Label at a glance#

ProductQ2 Oral Care Kit
Active ingredientHydrogen peroxide
Label structure11 sections

Indications and 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.

Dosage and administration

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.

Storage and handling

Store at room temperature.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydrogen Peroxide 1.5%

Purpose

OTC - PURPOSE SECTION

Oral Debriding Agent

Uses

INDICATIONS & USAGE SECTION

  • Aids in the removal of phlegm, mucus, or other secretions in the temporary relief of discomfort due to occasional sore throat and sore mouth.

Warnings

WARNINGS SECTION

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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 SECTION

  • 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 SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

  • Store at room temperature.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Purified Water, Glycerin, Flavor, Sodium Saccharin

Questions or Comments?

OTC - QUESTIONS SECTION

1-844-425-9273

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - Kit Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
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9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
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ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69697-983-012020-01-31C16284748780-19d75b9d0-5ed8-f424-e053-dadaa90a57ceHalyard 24-Hour Oral Care Kit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69697-983-01Q2 Oral Care Kit1 in 1 CARTONKIT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69697-983Q2 ORAL CARE KIT (HYDROGEN PEROXIDE) KIT [HALYARD HEALTH]1Legacy NDC, 1 package rows20160212_71d9d8eb-7ee4-46c1-a657-dc2b93ddf751.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69697-98369697-983-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
Water059QF0KO0RINGR
XylitolVCQ006KQ1EINGR
Sodium BenzoateOJ245FE5EUINGR
Aloe Vera Flower575DY8C1ERINGR
Propylene Glycol6DC9Q167V3INGR
Potassium Sorbate1VPU26JZZ4INGR
Sorbitol506T60A25RINGR
Hydroxypropyl Cellulose (Type H)RFW2ET671PINGR
Dimethicone92RU3N3Y1OINGR
Potassium Chloride660YQ98I10INGR
Hydrogen peroxideBBX060AN9VACTIB
Water059QF0KO0RIACT
GlycerinPDC6A3C0OXIACT
MintFV98Z8GITPIACT
Saccharin Sodium DihydrateSB8ZUX40TYIACT
Water059QF0KO0RINGR
Benzoic Acid8SKN0B0MIMINGR
Saccharin Sodium DihydrateSB8ZUX40TYINGR
Sodium BenzoateOJ245FE5EUINGR
GlycerinPDC6A3C0OXINGR
Cetylpyridinium ChlorideD9OM4SK49PINGR
D&C Green No. 58J6RDU8L9XINGR
Sorbitol506T60A25RINGR
MintFV98Z8GITPINGR

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
78261de9-4192-4e88-a4e4-77dd7f82935871d9d8eb-7ee4-46c1-a657-dc2b93ddf7512016-01-25WarningsExact identifier
spl id: 78261de9-4192-4e88-a4e4-77dd7f829358
spl set id: 71d9d8eb-7ee4-46c1-a657-dc2b93ddf751

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.