FDA.reportPublic FDA data

CVS Pharmacy

Manufacturer
CVS Pharmacy | Lornamead Products
Effective date
2026-01-08
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
monthly-update
Hydrated at
2026-06-03 17:51:51

Label at a glance#

ProductCVS Pharmacy Pro Defense
Active ingredientSTANNOUS FLUORIDE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Stannous Fluoride (0.454% w/w)

OTC - PURPOSE SECTION

Purpose

Anticavity/Antigingiviitis

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, discontinue use if irritation occurs.

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 signs or 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 accidently 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 directed by a dentist or doctor. Minimize swallowing. Spit out after brushing.
  • To minimize swallowing for children under 6 years of age, use a pea-sized amount and supervise brushing until good habits are established.

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

OTHER SAFETY INFORMATION

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 by your dentist.
  • This product is specially formulated to help prevent staining.
  • Store below 77F (25C)
  • 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

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

©2017 CVS/pharmacy

CVS.com 1-800-SHOP CVS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton LabelCarton Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpastePSN10
416784stannous fluoride 0.00454 MG/MG ToothpasteSCD10
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSY10
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSY10
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSY10

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-872-19CVS PharmacyPro Defense1 in 1 CARTONPASTE, DENTIFRICE110
69842-872-19CVS PharmacyPro Defense96.4 g in 1 TUBEPASTE, DENTIFRICE96.410

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69842-87269842-872-19

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
GLYCERINPDC6A3C0OXIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
WATER059QF0KO0RIACT
SODIUM TRIPOLYPHOSPHATE ANHYDROUS9SW4PFD2FZIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
HYDRATED SILICAY6O7T4G8P9IACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
SODIUM LAURYL SULFATE368GB5141JIACT
STANNOUS FLUORIDE3FTR44B32QACTIM

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
92025-01-20full-release2026-06-01 00:53:13

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
CVS Pharmacy Pro DefenseFLUORIDECVS Pharmacy445ec57e-dc3c-49a0-8ca9-4806fcdc03032026-01-08WarningsExact identifier
ndc (package): 69842-872-19
ndc (product): 69842-872
ndc11 (package): 69842087219
spl id: 47e6024c-0157-bf83-e063-6294a90a94cf
spl set id: 445ec57e-dc3c-49a0-8ca9-4806fcdc0303

Reported adverse events (FAERS/openFDA)#

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