Dr.pik Oral Care Gargle

Manufacturer
Dr.pik Co.,ltd | Ecoworld Co .,ltd
Effective date
2023-08-27
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:26:49

Label at a glance#

ProductDr.pik Oral Care Gargle
Active ingredientSODIUM FLUORIDE
Label structure8 sections

Indications and uses

Uses: Helps prevent dental caries and remove bad breath.

Dosage and administration

Directions: Add 15ml of Dr.pik Oral Care Gargle measured by the cap to the supply tank of Vacuum Oral Care. After filling water up to the line of the supply tank, add Dr.pik Oral Care Gargle. Do not use the solution without diluting for gargling purpose.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active ingredients: Sodium fluoride 0.05%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Inactive ingredients:
Water, Alcohol, Xyitol, Flavor (apple spearmint), L-Menthol, Acetic acid, Sodium benzoate, Sodium citrate, Citric acid, Stevioside, Sodium saccharin

PURPOSE

OTC - PURPOSE SECTION

Purpose: Anticaries

WARNINGS

WARNINGS SECTION

Warnings:
1) Keep the prescribed usage, capacity. 2) When using to children, please use under the guidance and supervision of the guardian. 3) Since this product is high in concentration, be sure to add it to the water supply tank of the Dr.pik’s 'Vacuum Oral Care'. 4) Use only for oral cleaning. Do not use besides the intended use. If large quantities have been swallowed, consult a physician immediately. 5) Children under 6 years old, please do not use without instructions from a pharmacist or doctor. 6) Please keep out of reach of children. 7) Avoid direct sunlight, keep as cool as possible. 8) Please do not put in another container for quality preservation.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Please keep out of reach of children.

Uses

INDICATIONS & USAGE SECTION

Uses:
Helps prevent dental caries and remove bad breath.

Directions

DOSAGE & ADMINISTRATION SECTION

Directions:
Add 15ml of Dr.pik Oral Care Gargle measured by the cap to the supply tank of Vacuum Oral Care.
After filling water up to the line of the supply tank, add Dr.pik Oral Care Gargle.
Do not use the solution without diluting for gargling purpose.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of containerImage of container

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72857-010-012023-08-27C16284748780-1ba0f9c33-59d0-a910-e053-dadaa90a0b856f82ab54-2f53-499f-8678-88998f36626b
72857-010-012021-01-29C16284748780-1ba0f9c33-59d0-a910-e053-dadaa90a0b856f82ab54-2f53-499f-8678-88998f36626b

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72857-01072857-010-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM

Source Document#

Source XML

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
03f0fd7a-3445-efaf-e063-6394a90a7f896f82ab54-2f53-499f-8678-88998f36626b2023-08-27WarningsExact identifier
spl id: 03f0fd7a-3445-efaf-e063-6394a90a7f89
spl set id: 6f82ab54-2f53-499f-8678-88998f36626b

Reported adverse events (FAERS/openFDA)#

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