GLEEM PROTECTION- stannous fluoride paste, dentifrice

GLEEM by

Drug Labeling and Warnings

GLEEM by is a Otc medication manufactured, distributed, or labeled by The Procter & Gamble Manufacturing Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

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

Purposes

Anticavity, antigingivitis toothpaste

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

Warnings

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

• 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

• 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

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?

1-855-510-8802

SPL UNCLASSIFIED SECTION

DISTR. BY PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 99 g Tube Carton

GLEEM

FLUORIDE TOOTHPASTE FOR ANTICAVITY AND ANTIGINGIVITIS

PROTECTION

CAVITY PROTECTION

NET WT 4.1 OZ (116 g)

INGREDIENTS AND APPEARANCE

GLEEM  PROTECTION
stannous fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69423-908
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.4 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
STANNOUS CHLORIDE (UNII: 1BQV3749L5)
SUCRALOSE (UNII: 96K6UQ3ZD4)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SORBITOL (UNII: 506T60A25R)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
ZINC CITRATE (UNII: K72I3DEX9B)
WATER (UNII: 059QF0KO0R)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM GLUCONATE (UNII: R6Q3791S76)
CARRAGEENAN (UNII: 5C69YCD2YJ)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
XANTHAN GUM (UNII: TTV12P4NEE)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color	blue	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69423-908-41	1 in 1 CARTON	01/04/2021
1		116 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	01/04/2021

Labeler - The Procter & Gamble Manufacturing Company (004238200)