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GLISTER MULTI-ACTION FLUORIDE- sodium fluoride pas te, dentifrice Access Bus iness Group, LLCDisclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if theycomply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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Glis ter Multi-action Fluoride Toothpaste
Active IngredientsSodium fluoride 0.21%
PurposeAnticavity
UsesAids in the prevention of dental cavities
WarningIf more than used for brushing is accidentally swallowed, get medical help or contact a Poison ControlCenter right away.
Keep out of reach of childrenunder 6 years of age
DirectionsDo not swallowAdults and children 2 years and over: brush teeth thoroughly after meals or at least twice a day oruse as directed by a dentist or doctorInstruct children under 6 years in good rinsing habits (to reduce swallowing)Supervise children as necessary until capable of using without supervisionChildren under 2 years, ask a dentist or doctor.
Inactive IngredientsWater, 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
With regular brushing, glister multi-action fluoride toothpaste helps remove plaque. This productcontains SYLODENT polishing agent which safely cleans and helps eliminate stains to whiten teeth. Toenhance your overall oral health, use the complete glister oral care system
Trademark is used by Access under license.
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
GLISTER MULTI-ACTION FLUORIDE sodium fluoride paste, dentifrice
Product InformationProduct T ype HUMAN OTC DRUG Ite m Code (Source ) NDC:10 0 56 -530
Route of Adminis tration TOPICAL
Access Business Group, LLC
Active Ingredient/Active MoietyIngredient Name Basis o f Strength Strength
SO DIUM FLUO RIDE (UNII: 8 ZYQ1474W7) (FLUORIDE ION - UNII:Q8 0 VPU40 8 O) FLUORIDE ION 2.1 mg in 1 g
Inactive IngredientsIngredient Name Strength
WATER (UNII: 0 59 QF0 KO0 R)
SO RBITO L (UNII: 50 6 T6 0 A25R)
HYDRATED SILICA (UNII: Y6 O7T4G8 P9 )
GLYCERIN (UNII: PDC6 A3C0 OX)
PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)
SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J)
XYLITO L (UNII: VCQ0 0 6 KQ1E)
CARBO XYMETHYLCELLULO SE SO DIUM (UNII: K6 79 OBS311)
PO LYETHYLENE GLYCO L (UNII: 3WJQ0 SDW1A)
TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)
XANTHAN GUM (UNII: TTV12P4NEE)
SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY)
METHYLPARABEN (UNII: A2I8 C7HI9 T)
PRO PYLPARABEN (UNII: Z8 IX2SC1OH)
FD&C BLUE NO . 1 (UNII: H3R47K3TBD)
Packaging# Item Code Package Description Marketing Start Date Marketing End Date1 NDC:10 0 56 -530 -6 5 1 in 1 BOX 0 4/11/20 11
1 6 5 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct
2 NDC:10 0 56 -530 -0 6 1 in 1 BOX 0 4/11/20 11
2 19 1 g in 1 TUBE; Type 1: Co nvenience Kit o f Co -Package
Marketing InformationMarke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date
OTC mo no graph fina l part355 0 4/11/20 11
Labeler - Access Bus iness Group, LLC (839830713)
Revised: 11/2020