Oral Pro Care

Manufacturer
Den-Mat Holdings, LLC
Effective date
2023-06-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:29:45

Label at a glance#

ProductOral Pro Care
Active ingredientSTANNOUS FLUORIDE
Label structure11 sections

Indications and uses

Aids in the prevention of dental cavities

Dosage and administration

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. Children under 2 years of age: Consult a dentist or doctor. Do not swallow. To minimize swallowing, use a pea-sized amount in children under 6. Instruct children under 6 years of age in good brushing and rinsing habits. Supervise children as necessary until...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Stannous Flouride 0.4% (0.12% w/v flouride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity

Uses

INDICATIONS & USAGE SECTION

Aids in the prevention of dental cavities

Warnings

WARNINGS SECTION

This is an anticavity flouride prevent treatment gel, not a toothpaste. Read directions carefully before using.

Using this product may produce surface staining of the teeth. Adequate tooth brushing may prevent stains which are not harmful or permanent and may be removed by a dentist.

Keep out of reach of children section

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. 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 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.
  • Children under 2 years of age: Consult a
    dentist or doctor.
  • Do not swallow.
  • To minimize swallowing, use a pea-sized
    amount in children under 6.
  • Instruct children under 6 years of age in
    good brushing and rinsing habits.
  • Supervise children as necessary until
    capable of using without supervision.

Other Information

OTHER SAFETY INFORMATION

For your protection, do not use if the tip under the cap is cut or tampered.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Ascorbic Acid, Carbomer, Citric Acid, Flavor, Glycerin, Triethanolamine

Questions or Comments?

DESCRIPTION SECTION

800-433-6628

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

OralProCare™

Clinical Strength

Cavity Protection Gel

Formulated with Stannous Flouride

Fresh Mint Flavor

Net Wt 4 oz.(113.4 g)

Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59883-60059883-600-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 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
1e69868b-6063-1f61-e063-6394a90aa2a6fd187009-9be8-5326-e053-6294a90a538b2024-07-29WarningsExact identifier
spl set id: fd187009-9be8-5326-e053-6294a90a538b

Reported adverse events (FAERS/openFDA)#

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