GLISTER MULTI-ACTION- sodium fluoride paste, dentifrice 
Access Business Group LLC

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Glister Multi-Action Toothpaste

Drug Facts

Active Ingredient

Sodium Fluoride 0.21%

Purpose

Anticavity

Use

Aids in the prevention of dental cavities.

Warnings

Keep out of reach of children

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center immediately. under 6 years of age.

Directions

• Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.

• Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing).

Supervise children as necessary until capable of using without supervision.

• Children under 2 years of age: Consult a dentist or doctor.

Inactive Ingredients

Water, Sorbitol, Hydrated Silica, Glycerin, Propylene Glycol, Sodium Lauryl Sulfate, Xylitol, Cellulose Gum, PEG-8, Flavor, Titanium Dioxide, Sodium Benzoate, Xanthan Gum, Sodium Saccharin, Blue No. 1

Package Labeling:50g

Label50g

Package Labeling:200g

Label200g

GLISTER MULTI-ACTION 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10056-415
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION2.1 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
XYLITOL (UNII: VCQ006KQ1E)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10056-415-001 in 1 CARTON03/22/2023
150 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:10056-415-011 in 1 CARTON03/22/2023
2200 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02103/22/2023
Labeler - Access Business Group LLC (839830713)

Revised: 10/2023
Document Id: 085bbc1a-0302-ea11-e063-6394a90a3391
Set id: e3f2c049-a0f5-4649-a4aa-11bdb252f951
Version: 2
Effective Time: 20231023
 
Access Business Group LLC