FDA.reportPublic FDA data

Dr.Pauhls TOOTHPAST E LIME MANDARIN FLAVOR

Manufacturer
CURESCRIPT | Kumho Dental Pharm. Co., Ltd.
Effective date
2018-07-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:56:26

Label at a glance#

ProductDr.Pauhls TOOTHPAST E LIME MANDARIN FLAVOR
Active ingredientSILICON DIOXIDE, PYRIDOXINE HYDROCHLORIDE
Label structure8 sections

Indications and uses

Uses: - Helps protect against cavities - reduce plaque - gum health - Helps protect against gingivitis, periodontitis - Helps freshen breath - brightening teeth

Dosage and administration

Directions: Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician Children 2 to 6 years: Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing) Children under 2 years: Ask a dentist or physician

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active ingredients: SILICA 13.0%, PYRIDOXINE HYDROCHLORIDE 0.05%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Inactive ingredients:

SORBITOL, SODIUM PCA, GLYCERIN, SODIUM LAURYL SULFATE, FLAVOR, CELLULOSE GUM, MENTHOL, XYLITOL, CITRUSGRANDIS (GRAPEFRUIT) SEED EXTRACT, SODIUM SACCHARIN HYDROXYAPATITE, CAMELLIA SINENSIS LEAF EXTRACT, CALENDULA OFFICINALIS FLOWER EXTRACT, ANTHEMIS NOBILIS FLOWER EXTRACT PROPOLIS EXTRACT

PURPOSE

OTC - PURPOSE SECTION

Purpose: Anti-plaque, Anti-caries, Anti-periodontitis

WARNINGS

WARNINGS SECTION

Warnings:

Keep out of the reach of children under 6 years of age.

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children under 6 years of age.

Uses

INDICATIONS & USAGE SECTION

Uses:

- Helps protect against cavities

- reduce plaque

- gum health

- Helps protect against gingivitis, periodontitis

- Helps freshen breath

- brightening teeth

Directions

DOSAGE & ADMINISTRATION SECTION

Directions:

Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician

Children 2 to 6 years: Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)

Children under 2 years: Ask a dentist or physician

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
PYRIDOXINE Pharmacologic Class Indexing1Indexing - Pharmacologic Class20170310

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-138809580720016GTIN-13: 8809580720016
EAN-13: 8809580720016
GTIN storage (14 digits): 08809580720016		mandarin carton.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72265-010-022020-01-31C16284748780-19d75b9cf-dee0-f424-e053-dadaa90a57ce4fc7c17d-0710-4d11-a503-e1fc37b3dcf9

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72265-010-01Dr.Pauhls TOOTHPAST E LIME MANDARIN FLAVOR100 g in 1 TUBEPASTE, DENTIFRICE1001
72265-010-02Dr.Pauhls TOOTHPAST E LIME MANDARIN FLAVOR1 in 1 CARTONPASTE, DENTIFRICE11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72265-010DR.PAUHLS TOOTHPAST E LIME MANDARIN FLAVOR (SILICON DIOXIDE, PYRIDOXINE HYDROCHLORIDE) PASTE, DENTIFRICE [CURESCRIPT]1Legacy NDC, 2 package rows20180726_4fc7c17d-0710-4d11-a503-e1fc37b3dcf9.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72265-01072265-010-01, 72265-010-02

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
SILICON DIOXIDEETJ7Z6XBU4ACTIB
PYRIDOXINE HYDROCHLORIDE68Y4CF58BVACTIM
SORBITOL506T60A25RIACT
SODIUM PYRROLIDONE CARBOXYLATE469OTG57A2IACT

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
f567cc0b-d62e-4a20-9899-e241f3e7bc8c4fc7c17d-0710-4d11-a503-e1fc37b3dcf92018-07-26WarningsExact identifier
spl id: f567cc0b-d62e-4a20-9899-e241f3e7bc8c
spl set id: 4fc7c17d-0710-4d11-a503-e1fc37b3dcf9

Reported adverse events (FAERS/openFDA)#

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