FDA.reportPublic FDA data

Rite Aid Pro Defense

Manufacturer
Rite Aid | Lornamead Inc.
Effective date
2023-01-11
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
legacy-cache
Hydrated at
2026-08-01 21:40:48

Label at a glance#

ProductRite Aid Pro Defense Whitening
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% (w/w)

OTC - PURPOSE SECTION

Purpose

Anticavity / Anti-gingivitis

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 - 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

  • 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.

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

DISTRIBUTED BY:

RITE AID

30 HUNTER LANE

CAMP HILL, PA 17011

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RITE AID® PHARMACY

oral care

pro defense

daily fluoride anticavity & anti-gingivitis toothpaste

whitening

NET WT 3.4 OZ (96.4 g)

RA PRO DEFENSE 2821284R1RA PRO DEFENSE 2821284R1

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
11822-603411822-6034-9

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
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
SODIUM LAURYL SULFATE368GB5141JIACT
GLYCERINPDC6A3C0OXIACT
HYDRATED SILICAY6O7T4G8P9IACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
SODIUM TRIPOLYPHOSPHATE ANHYDROUS9SW4PFD2FZIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
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
441e0d43-6e64-2e8c-e063-6394a90a0fd783374382-5ea7-79c8-e053-2991aa0a4e1d2025-11-21WarningsExact identifier
spl set id: 83374382-5ea7-79c8-e053-2991aa0a4e1d

Reported adverse events (FAERS/openFDA)#

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