Pure Mouth Liquid

Manufacturer
On On Co., Ltd.
Effective date
2019-02-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:58:33

Label at a glance#

ProductPure Mouth Liquid
Active ingredientSODIUM FLUORIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

sodium fluoride

INACTIVE INGREDIENT SECTION

Sodium fluoride
Sodium saccharin
DL-Alanine
Citric acid
Sodium citrate
Xylitol
Green extract
Licorice extract
Mugwort extract
Ginger Tincture
Sodium benzoate
l-menthol
Spearmint flavor
Purified water

OTC - PURPOSE SECTION

Remove bad breath, prevent tooth decay

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reach of the children

INDICATIONS & USAGE SECTION

Use twice a day (morning and evening), use 10-15ml for one time,
take your mouth for about 30 seconds Rinse and spit out

WARNINGS SECTION

Keep the prescribed usage, capacity.
When using in children, please use under the guidance and supervision of the guardian.
Use only for mouthwash, do not use for internal use, guitar)
Do not use for children under 6 years old unless directed by a pharmacist or doctor.

DOSAGE & ADMINISTRATION SECTION

for oral use only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72875-0001-12021-01-29C16284748780-1ba0f9c33-24b8-a910-e053-dadaa90a0b85Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72875-0001-1Pure Mouth Liquid11 mL in 1 POUCHLIQUID111

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72875-0001PURE MOUTH LIQUID (SODIUM FLUORIDE) LIQUID [ON ON CO., LTD.]1Legacy NDC, 1 package rows20190215_817b98ed-c322-da5a-e053-2a91aa0a326e.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72875-000172875-0001-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

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
817aecc5-69fe-06d9-e053-2a91aa0aaca3817b98ed-c322-da5a-e053-2a91aa0a326e2019-02-09WarningsExact identifier
spl id: 817aecc5-69fe-06d9-e053-2a91aa0aaca3
spl set id: 817b98ed-c322-da5a-e053-2a91aa0a326e

Reported adverse events (FAERS/openFDA)#

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