GLEEM by The Procter & Gamble Manufacturing Company GLEEM Sensitivity

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]

GLEEM SENSITIVITY- stannous fluoride paste, dentifrice 
The Procter & Gamble Manufacturing Company

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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GLEEM Sensitivity

Drug Facts

Active ingredient

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

Purposes

Anticavity, antigingivitis, antisensitivity 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
• builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact

Warnings

When using this product do not use for sensitivity longer than four weeks unless recommended by a dentist.

Stop use and ask a dentist if the sensitivity problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care.

Keep out of reach of children. 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. & older: apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute twice a day (morning and evening) or as recommended by a dentist. Make sure to brush all sensitive areas of the teeth.
• 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, carrageenan, sodium gluconate, flavor, xanthan gum, zinc citrate, stannous chloride, sodium hydroxide, sodium saccharin, sucralose, titanium dioxide, blue 1

Questions?

1-855-210-8802

DISTR. BY PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 116 g Tube Carton

GLEEM

FLUORIDE TOOTHPASTE FOR ANTICAVITY, ANTIGINGIVITIS AND SENSITIVE TEETH

SENSITIVITY

HELPS RELIEVE TOOTH SENSITIVITY

NET WT 4.1 OZ (116 g)

GLEEM  SENSITIVITY
stannous fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69423-944
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
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SORBITOL (UNII: 506T60A25R)
ZINC CITRATE (UNII: K72I3DEX9B)
STANNOUS CHLORIDE (UNII: 1BQV3749L5)
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)
SUCRALOSE (UNII: 96K6UQ3ZD4)

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: 69423-944-41	1 in 1 CARTON	03/01/2021
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 final	part355	03/01/2021	09/26/2023

Labeler - The Procter & Gamble Manufacturing Company (004238200)

Revised: 9/2023

Document Id: 0644f135-6dbd-a8d6-e063-6394a90a07d0

34390-5

Set id: c6b1a0a8-0546-17f0-e053-2a95a90aaa75

Version: 3

Effective Time: 20230926

 

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