dailymed - glister multi-action fluoride toothpaste

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