UNIWELL 8575 SALT

Manufacturer
SOLM Co., Ltd.
Effective date
2019-12-22
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:02:20

Label at a glance#

ProductUNIWELL 8575 SALT
Active ingredientROSIN
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Rosin

INACTIVE INGREDIENT SECTION

Sodium chloride

OTC - PURPOSE SECTION

for dental care

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reach of the children

INDICATIONS & USAGE SECTION

use when is needed

WARNINGS SECTION

- do not swallow when using this product

- if more than used for rinsing is accidentally swallowed, get medical helps or contact a poison control center right away

DOSAGE & ADMINISTRATION SECTION

Hold 1 grams in mouth for 1~2 minutes then rinse out with water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ROSIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70706-1003-12021-01-29C16284748780-1ba0f9c33-2a67-a910-e053-dadaa90a0b8532b2f1a2-6307-74f8-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70706-1003-1UNIWELL 8575 SALT75 g in 1 PACKAGEPOWDER, DENTIFRICE753

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70706-1003UNIWELL 8575 SALT (ROSIN) POWDER, DENTIFRICE [SOLM CO., LTD.]3Legacy NDC, 1 package rows20191227_32b2f1a2-6307-74f8-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70706-100370706-1003-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM CHLORIDE451W47IQ8XIACT
ROSIN88S87KL877ACTIB

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
9a567ce3-5634-6b9f-e053-2a95a90a982332b2f1a2-6307-74f8-e054-00144ff8d46c2019-12-22WarningsExact identifier
spl id: 9a567ce3-5634-6b9f-e053-2a95a90a9823
spl set id: 32b2f1a2-6307-74f8-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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