Dr.Althea I am Natural ToothpasteForAdults

Manufacturer
Dr. Althea | Kumho Dental Pharm Co Ltd
Effective date
2018-03-22
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:54:58

Label at a glance#

ProductDr.Althea I am Natural ToothpasteForAdults
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

SODIUM MONOFLUOROPHOSPHATE, SILICA, PYRIDOXINE HCI, ALCLOXA

OTC - PURPOSE SECTION

Aids in the prevention of dental cavities.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

INDICATIONS & USAGE SECTION

How to use:

1) Squeeze toothpaste on to toothbrush.
2) Brush thoroughly at least twice a day.
3) Brush for 3+ minutes.
4) Rinse out thoroughly with water.

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 doctor.

■ Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing).

■ Supervise children as necessary until capable of using without supervision.

■ Children under 2 years of age: Consult a dentist or doctor.

WARNINGS SECTION

Cautions:
1) If following symptoms occur after product use, stop using immediately: red spots, swelling, itchiness, and other skin irritations. 2) Avoid contact with eyes and open wounds. 3) Keep out of reach of children. 4) Do not store at high/low temperature. 5) Avoid direct sunlight.

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

INACTIVE INGREDIENT SECTION

SILVER, HYDRATED SILICA, CELLULOSE GUM, SORBITIOL, GLYCERIN, PEG-32, XYLITOL, MENTHOL, WATER, ETC.

DOSAGE & ADMINISTRATION SECTION

For dental use only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

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
70905-0017-12020-01-31C16284748780-19d75b9cf-e67b-f424-e053-dadaa90a57ce67fac30f-f27a-a186-e053-2a91aa0a69d7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70905-0017-1Dr.Althea I am Natural ToothpasteForAdults120 g in 1 TUBEPASTE, DENTIFRICE1202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70905-0017DR.ALTHEA I AM NATURAL TOOTHPASTEFORADULTS (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [DR. ALTHEA]2Legacy NDC, 1 package rows20180322_67fac30f-f27a-a186-e053-2a91aa0a69d7.zip

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
70905-001770905-0017-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 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
67fb2f55-bcf2-3c64-e053-2991aa0a4f4b67fac30f-f27a-a186-e053-2a91aa0a69d72018-03-22WarningsExact identifier
spl id: 67fb2f55-bcf2-3c64-e053-2991aa0a4f4b
spl set id: 67fac30f-f27a-a186-e053-2a91aa0a69d7

Reported adverse events (FAERS/openFDA)#

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