FDA.reportPublic FDA data

Pro Defense

Manufacturer
CVS Pharmacy | Lornamead Inc.
Effective date
2020-06-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:24:07

Label at a glance#

ProductPro Defense Mint
Active ingredientSTANNOUS FLUORIDE
Label structure10 sections

Storage and handling

Other information products containing stannous fluoride may cause surface staining of the teeth. Adequate tooth brushing may prevent these stains which are not harmful or permanent and may be removed your dentist. This product is specifically formulated to help prevent staining store below 77°F (25°C) Keep tube capped when not in use

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Stannous fluoride 0.454% (0.15% w/v fluoride ion)

OTC - PURPOSE SECTION

Purpose

Anticavity / Antigingivitis

INDICATIONS & USAGE SECTION

Uses

  • aids in the prevention of dental cavities
  • helps control bleeding gums
  • helps interfere with harmful effects of plaque associated with gingivitis

WARNINGS SECTION

Warnings

OTC - WHEN USING SECTION

When using this product, if irritation occurs discontinue use.

OTC - STOP USE SECTION

Stop use and ask a dentist if:

  • gingivitis, bleeding or redness persists for more than 2 weeks
  • if you have painful or swollen gums, pus from the gum line, loose teeth or increasing space between teeth. These may be symptoms of periodontis, a serious form of gum disease

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.

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 and not more than 3 times a day or as day or as directed by a dentist or doctor. Minimize swallowing. Spit out after brushing

Children under 2 years of age: consult a dentist or doctor

STORAGE AND HANDLING SECTION

Other information

  • products containing stannous fluoride may cause surface staining of the teeth. Adequate tooth brushing may prevent these stains which are not harmful or permanent and may be removed your dentist.
  • This product is specifically formulated to help prevent staining
  • store below 77°F (25°C)
  • Keep tube capped when not in use

INACTIVE INGREDIENT SECTION

Inactive ingredients Glycerin, Water, Hydrated Silica, Pentasodium Triphosphate, Cellulose Gum, Cocamidopropyl Betaine, Titanium Dioxide, Sodium Lauryl Sulfate, Flavor, Sodium Saccharin

SPL UNCLASSIFIED SECTION

Contains stannous fluoride, clinically proven to help control bleeding gums.

Distributed by:

CVS Pharmacy, Inc.

One CVS Drive

Woonsocket, RI 02895

©2018 CVS/pharmacy

CVS.com

1-800-SHOP CVS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS Health™

Pro Defense Clean Mint

DAILY FLUORIDE ANTI-CAVITY & ANTI-GINGIVITIS TOOTHPASTE

  • Helps prevent bleeding gums
  • For healthy gums and strong teeth

NET WT 3.4 OZ (96.4 g)

CVS_Parodontax_CleanMint_Ctn_F8015279CVS_Parodontax_CleanMint_Ctn_F8015279

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69842-25469842-254-19

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
SACCHARIN SODIUMSB8ZUX40TYIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
SODIUM LAURYL SULFATE368GB5141JIACT
GLYCERINPDC6A3C0OXIACT
HYDRATED SILICAY6O7T4G8P9IACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
SODIUM TRIPOLYPHOSPHATE ANHYDROUS9SW4PFD2FZIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
WATER059QF0KO0RIACT
STANNOUS FLUORIDE3FTR44B32QACTIM

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
c73dc2c0-c46f-43cc-e053-2a95a90ae42981699836-16c7-bca3-e053-2991aa0aef812021-07-16WarningsExact identifier
spl set id: 81699836-16c7-bca3-e053-2991aa0aef81

Reported adverse events (FAERS/openFDA)#

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