FDA.reportPublic FDA data

GLEEM

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2025-08-06
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:09:31

Label at a glance#

ProductGLEEM Protection
Active ingredientSTANNOUS FLUORIDE
Label structure11 sections

Indications and uses

aids in the prevention of cavities helps prevent gingivitis helps interfere with the harmful effects of plaque associated with gingivitis helps control plaque bacteria that contribute to the development of gingivitis

Dosage and administration

adults and children 12 yrs. of age & older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician. do not swallow children under 12 yrs.: ask a dentist

Storage and handling

products containing stannous fluoride may produce surface staining of the teeth adequate toothbrushing 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 see your dentist regularly

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Stannous fluoride 0.454% (0.14% w/v fluoride ion)

Purposes

OTC - PURPOSE SECTION

Anticavity, antigingivitis toothpaste

Uses

INDICATIONS & USAGE SECTION

  • aids in the prevention of cavities
  • helps prevent gingivitis
  • helps interfere with the harmful effects of plaque associated with gingivitis
  • helps control plaque bacteria that contribute to the development of gingivitis

Warnings

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 12 yrs. of age. 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 12 yrs. of age & older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician.
  • do not swallow
  • children under 12 yrs.: ask a dentist

Other information

STORAGE AND HANDLING SECTION

  • products containing stannous fluoride may produce surface staining of the teeth
  • adequate toothbrushing 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
  • see your dentist regularly

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, sorbitol, hydrated silica, sodium lauryl sulfate, sodium gluconate, carrageenan, flavor, sodium citrate, xanthan gum, zinc citrate, sodium hydroxide, stannous chloride, sodium saccharin, sucralose, titanium dioxide, blue 1

Questions?

OTC - QUESTIONS SECTION

1-855-510-8802

SPL UNCLASSIFIED SECTION

DISTR. BY PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 99 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GLEEM

FLUORIDE TOOTHPASTE FOR ANTICAVITY AND ANTIGINGIVITIS

PROTECTION

CAVITY PROTECTION

NET WT 4.1 OZ (116 g)

6942390869423908

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69423-90869423-908-41

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
STANNOUS CHLORIDE1BQV3749L5IACT
SUCRALOSE96K6UQ3ZD4IACT
HYDRATED SILICAY6O7T4G8P9IACT
SORBITOL506T60A25RIACT
SODIUM CITRATE1Q73Q2JULRIACT
ZINC CITRATEK72I3DEX9BIACT
WATER059QF0KO0RIACT
SODIUM LAURYL SULFATE368GB5141JIACT
SODIUM GLUCONATER6Q3791S76IACT
CARRAGEENAN5C69YCD2YJIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
XANTHAN GUMTTV12P4NEEIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
SODIUM HYDROXIDE55X04QC32IIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
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
40aa5e90-0f61-6e88-e063-6294a90a3a8ac3147bdd-bc55-defa-e053-2995a90adfb52025-10-08WarningsExact identifier
spl set id: c3147bdd-bc55-defa-e053-2995a90adfb5

Reported adverse events (FAERS/openFDA)#

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