Fluoride with Baking Soda

Manufacturer
tropical degil cosmetics industries ltd
Effective date
2023-01-05
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:53:22

Label at a glance#

ProductOrbitol Fluoride Toothpaste with Baking Soda
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure8 sections

Dosage and administration

Adults and children 6 years of age and older: Brush teeth thoroughly, preferrably after each meal or at least twice a day, or as directed by a dentist or doctor. Instruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 6 years of age: Do not use unless directed by a dentist or doc...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium monofluorophosphate 1.1% w/w (1450 ppm fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

Aids in the prevention of dental cavities

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

Do not use if you are sensitive to any of the ingredients in this prouduct.

When using this product

OTC - WHEN USING SECTION

When using this product avoid contact with eyes.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of 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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 6 years of age and older: Brush teeth thoroughly, preferrably after each meal or at least twice a day, or as directed by a dentist or doctor. Instruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision.
  • Children under 6 years of age: Do not use unless directed by a dentist or doctor.

Inactive ingredients

INACTIVE INGREDIENT SECTION

sorbitol, water, calcium carbonate, silica, cellulose gum, sodium lauryl sulfate, flavor, sodium bicarbonate, sodium saccharin, sodium benzoate, benzoic acid, zinc citrate, limonene.

Other information

OTHER SAFETY INFORMATION

Other information store below 30°C (86°F).

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDPPDP

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62685-230-042025-01-30C16284748780-12cef2736-b1dc-d83d-e063-dadaa90ab31fOrbitol Fluoride Toothpaste with Baking Soda

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62685-230-04Orbitol Fluoride Toothpaste with Baking Soda1 in 1 BOXPASTE13
62685-230-04Orbitol Fluoride Toothpaste with Baking Soda145 g in 1 TUBEPASTE1453

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62685-230ORBITOL FLUORIDE TOOTHPASTE WITH BAKING SODA (SODIUM MONOFLUOROPHOSPHATE) PASTE [TROPICAL DEGIL COSMETICS INDUSTRIES LTD]3Legacy NDC, 2 package rows20230120_cd018c44-3257-3ed6-e053-2a95a90ae3f3.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62685-23062685-230-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 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
f183f9bf-5589-4a99-e053-2995a90a0878cd018c44-3257-3ed6-e053-2a95a90ae3f32023-01-05WarningsExact identifier
spl id: f183f9bf-5589-4a99-e053-2995a90a0878
spl set id: cd018c44-3257-3ed6-e053-2a95a90ae3f3