Orthocare

Manufacturer
Orthosciences, Inc.
Effective date
2023-11-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:18:05

Label at a glance#

ProductOrthocare
Active ingredientSODIUM FLUORIDE
Label structure9 sections

Dosage and administration

Adults and children 2 years of age and older: Use a pea sized amount and 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's brushing until good habits are established. Children under 2 years: Consult a dentist or doctor.

Label contents#

Full prescribing information#

Inactive Ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 0.24% (0.15% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

Aids in the prevention of dental cavities.

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Other Information:

OTHER SAFETY INFORMATION

For your protection, this tube has a foil seal under the cap.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 2 years of age and older: Use a pea sized amount and 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's brushing until good habits are established.
  • Children under 2 years: Consult a dentist or doctor.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Sorbitol, Hydrated Silica, Water, Glycerin, PEG-12, Lysine, Arginine, Sodium Lauryl Sulfate, Titanium Dioxide, Flavor, Cellulose Gum, Alanine, Sodium Benzoate, Disodium Phospate, Sodium Saccharin, FD&C Blue #1

Questions?

OTC - QUESTIONS SECTION

1-833-261-0246

Principal Display

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

OrthoSciences™

ORTHOCARE

Specially formulated for those with braces

NET WT. 4.4 OZ. (125 grams) Anticavity Fluoride Toothpaste

orthocare_toothpaste_image.jpgorthocare_toothpaste_image.jpg

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73051-075473051-0754-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 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
28f34819-44f9-0b5a-e063-6294a90a734286305ff0-3d65-7109-e053-2991aa0a408b2024-12-10WarningsExact identifier
spl set id: 86305ff0-3d65-7109-e053-2991aa0a408b

Reported adverse events (FAERS/openFDA)#

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