GLISTER MULTI-ACTION FLUORIDE- sodium fluoride paste, dentifrice

Glister Multi-Action Fluoride by

Drug Labeling and Warnings

Glister Multi-Action Fluoride by is a Otc medication manufactured, distributed, or labeled by Access Business Group, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Sodium fluoride 0.21%

Purpose

Anticavity

Uses

Aids in the prevention of dental cavities

Warning

If more than used for brushing is accidentally swallowed, get medical help or contact  a Poison Control Center right away.

Keep out of reach of children

under 6 years of age

Directions

• Do not swallow
• Adults and children 2 years and over: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist or doctor
• Instruct children under 6 years in good rinsing habits (to reduce swallowing)
• Supervise children as necessary until capable of using without supervision
• Children under 2 years, ask a dentist or doctor.
  

Inactive Ingredients

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

SPL UNCLASSIFIED SECTION

With regular brushing, glister multi-action fluoride toothpaste helps remove plaque. This product contains SYLODENT polishing agent which safely cleans and helps eliminate stains to whiten teeth. To enhance your overall oral health, use the complete glister oral care system

Trademark is used by Access under license.

PRINCIPAL DISPLAY PANEL

Dist. by Access Business Group International LLC, Ada, MI 49355

Glister multi-action fluoride toothpaste

Multiple action

whitens teeth

removes plaque

fights cavities

safely cleans

freshens breath

promotes remineralization

MADE IN U.S.A.

Package Labeling: 10056-530-06

Package Labeling: 10056-530-65

INGREDIENTS AND APPEARANCE

GLISTER MULTI-ACTION FLUORIDE 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10056-530
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	2.1 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 (UNII: K679OBS311)
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
XANTHAN GUM (UNII: TTV12P4NEE)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10056-530-65	1 in 1 BOX	04/11/2011
1		65 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 10056-530-06	1 in 1 BOX	04/11/2011
2		191 g in 1 TUBE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	04/11/2011

Labeler - Access Business Group, LLC (839830713)